- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00976820
Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.
This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M3
- GSK Investigational Site
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Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- GSK Investigational Site
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
- GSK Investigational Site
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Hamilton, Ontario, Canada, L8L 5G8
- GSK Investigational Site
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Newmarket, Ontario, Canada, L3Y 5G8
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3E 1H5
- GSK Investigational Site
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Toronto, Ontario, Canada, M9V 4B4
- GSK Investigational Site
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Toronto, Ontario, Canada, M5G 1N8
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- GSK Investigational Site
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Quebec City, Quebec, Canada, G1V 4T3
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 1Z1
- GSK Investigational Site
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Arkansas
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Conway, Arkansas, Forente stater, 72034
- GSK Investigational Site
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Little Rock, Arkansas, Forente stater, 72202
- GSK Investigational Site
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California
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Frisco, California, Forente stater, 94102
- GSK Investigational Site
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Sacramento, California, Forente stater, 95816
- GSK Investigational Site
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Kansas
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Arkansas City, Kansas, Forente stater, 67005
- GSK Investigational Site
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Wichita, Kansas, Forente stater, 67205
- GSK Investigational Site
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Kentucky
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Bardstown, Kentucky, Forente stater, 40004
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
- GSK Investigational Site
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Minnesota
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Saint Paul, Minnesota, Forente stater, 55108
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, Forente stater, 68134
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Forente stater, 44121
- GSK Investigational Site
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Tennessee
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Kingsport, Tennessee, Forente stater, 37660
- GSK Investigational Site
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Texas
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Austin, Texas, Forente stater, 78705
- GSK Investigational Site
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Fort Worth, Texas, Forente stater, 76135
- GSK Investigational Site
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San Angelo, Texas, Forente stater, 76904
- GSK Investigational Site
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Utah
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Orem, Utah, Forente stater, 84057
- GSK Investigational Site
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S. Jordan, Utah, Forente stater, 84095
- GSK Investigational Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Safety laboratory test results within the parameters specified in the protocol.
- Parent/ LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that their parent(s)/ LAR can and will comply with the requirements of the protocol.
- Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.
Exclusion Criteria:
- Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Administration of any licensed vaccine within 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.
- Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Child in care.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Arepanrix/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval.
The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age].
The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
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Two intramuscular injections
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Eksperimentell: Arepanrix/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval.
The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age).
The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
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Two intramuscular injections
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Eksperimentell: GSK2340273A/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval.
The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age).
The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
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Two intramuscular injections
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Eksperimentell: GSK2340273A/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval.
The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age).
The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
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Two intramuscular injections
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Tidsramme: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
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At Day 21
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Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
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At Day 21
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Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
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At Day 21
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Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 42
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
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At Day 42
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Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 42
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
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At Day 42
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Tidsramme: At Day 0
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 0
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Tidsramme: At Day 21
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 21
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 0
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 0
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 21
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 21
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 0
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 0
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 21
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 21
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
Tidsramme: At Day 0
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 0
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 42
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 42
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
Tidsramme: At Day 0
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 0
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Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 42
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A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Tidsramme: At Day 21
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SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
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At Day 21
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 21
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SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
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At Day 21
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 21
|
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
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At Day 21
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 42
|
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 42
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SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
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At Day 42
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
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A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 21
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Number of Seropositive Subjects for HI Antibodies - First Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 21
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Number of Seropositive Subjects for HI Antibodies - Second Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 21
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Number of Seropositive Subjects for HI Antibodies - First Analysis
Tidsramme: At Day 0 (PRE) and at Day 42
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 42
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Number of Seropositive Subjects for HI Antibodies - Second Analysis
Tidsramme: At Day 0 (PRE) and at Day 42
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 42
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Number of Seropositive Subjects for HI Antibodies
Tidsramme: At Day 0 (PRE) and at Day 182
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A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10.
The vaccine strain assessed was Flu A/CAL/7/09.
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At Day 0 (PRE) and at Day 182
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
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Titers are presented as geometric mean titers (GMTs) and measured in titers.
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At Day 0 (PRE) and at Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 21
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 0 (PRE) and at Day 21
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 21
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Tidsramme: At Day 0 (PRE) and at Day 42
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 42
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Tidsramme: At Day 0 (PRE) and at Day 42
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 42
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 182
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 182
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
Tidsramme: At Day 182
|
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
|
At Day 182
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 182
|
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
|
At Day 0 (PRE) and at Day 182
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
Tidsramme: At Day 182
|
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
|
At Day 182
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Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 21
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8.
The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
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At Day 0 (PRE) and at Day 21
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Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 21
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 21
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Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 42
|
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8.
The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
|
At Day 0 (PRE) and at Day 42
|
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Tidsramme: At Day 0 (PRE) and at Day 42
|
Titers are presented as geometric mean titers (GMTs) and measured in titers.
|
At Day 0 (PRE) and at Day 42
|
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Tidsramme: At Day 0 (PRE) and at Day 21
|
Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination.
The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
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At Day 0 (PRE) and at Day 21
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Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Tidsramme: At Day 0 (PRE) and at Day 42
|
Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination.
The vaccine strain assessed was Flu A/Neth/602/09.
|
At Day 0 (PRE) and at Day 42
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period
|
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 loss of appetite= not eating at all.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period
|
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Tidsramme: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
Tidsramme: At Day 0 (PRE), at Day 7 and at Day 21
|
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC].
Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7 and at Day 21
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
Tidsramme: At Day 0 (PRE), at Day 7 and at Day 21
|
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN].
Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7 and at Day 21
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
Tidsramme: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC].
Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
Tidsramme: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN].
Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
Tidsramme: At Day 0 (PRE), at Day 7 and at Day 21
|
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7 and at Day 21
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
Tidsramme: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN].
Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
|
Number of Subjects With Haematological Laboratory Abnormalities
Tidsramme: At Day 182
|
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC].
Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 182
|
Number of Subjects With Biochemical Laboratory Abnormalities
Tidsramme: At Day 182
|
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN].
Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
|
At Day 182
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
Tidsramme: Within 21 days (Days 0-20) post vaccination
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
Within 21 days (Days 0-20) post vaccination
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
Tidsramme: Within 42 days (Days 0-41) post vaccination
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
Within 42 days (Days 0-41) post vaccination
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis
Tidsramme: Within 41 days (Days 0-40) post vaccination
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
Within 41 days (Days 0-40) post vaccination
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Tidsramme: Within 84 days (Days 0-83) post vaccination
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
Within 84 days (Days 0-83) post vaccination
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis
Tidsramme: Within 21 days (Days 0-20) post vaccination
|
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
|
Within 21 days (Days 0-20) post vaccination
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis
Tidsramme: Within 41 days (Days 0-40) post vaccination
|
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
|
Within 41 days (Days 0-40) post vaccination
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis
Tidsramme: Within 42 days (Days 0-41) post vaccination
|
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
|
Within 42 days (Days 0-41) post vaccination
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Tidsramme: Within 182 days (Days 0-181) post vaccination
|
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
|
Within 182 days (Days 0-181) post vaccination
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Tidsramme: Throughout the entire study period (Day 0 - Day 385)
|
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
|
Throughout the entire study period (Day 0 - Day 385)
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis
Tidsramme: Within 21 days (Days 0-20) post vaccination
|
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
|
Within 21 days (Days 0-20) post vaccination
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis
Tidsramme: Within 42 days (Days 0-41) post vaccination
|
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
|
Within 42 days (Days 0-41) post vaccination
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis
Tidsramme: Within 42 days (Days 0-41) post vaccination
|
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
|
Within 42 days (Days 0-41) post vaccination
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Tidsramme: Within 182 days (Days 0-181) post vaccination
|
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
|
Within 182 days (Days 0-181) post vaccination
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Tidsramme: Throughout the entire study period (Day 0 - Day 385)
|
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
|
Throughout the entire study period (Day 0 - Day 385)
|
Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis
Tidsramme: Within 21 days (Days 0-20) post vaccination
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Within 21 days (Days 0-20) post vaccination
|
Number of Subjects With Serious Adverse Events (SAEs) - First Analysis
Tidsramme: Within 42 days (Days 0-41) post vaccination
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Within 42 days (Days 0-41) post vaccination
|
Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis
Tidsramme: Within 42 days (Day 0-41) post vaccination
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Within 42 days (Day 0-41) post vaccination
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: Within 182 days (Days 0-181) post vaccination
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Within 182 days (Days 0-181) post vaccination
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: Throughout the entire study period (Day 0 - Day 385)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
Throughout the entire study period (Day 0 - Day 385)
|
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Andre studie-ID-numre
- 113482
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Studiedata/dokumenter
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Klinisk studierapport
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Skjema for informert samtykke
Informasjonsidentifikator: 113482Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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