Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
31 juli 2017 uppdaterad av: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
210
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bilbao, Spanien, 48013
- GSK Investigational Site
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Burgos, Spanien, 09005
- GSK Investigational Site
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Madrid, Spanien, 28046
- GSK Investigational Site
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Móstoles/Madrid, Spanien, 28935
- GSK Investigational Site
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Sevilla, Spanien, 41013
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år till 17 år (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- 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.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Grupp A
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Two primary intramuscular (IM) injections and a booster IM injection
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Tidsram: At Day 0
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The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 0
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Tidsram: At Day 42
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Day 42
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Titers for Serum HI Antibodies
Tidsram: At Day 0
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 0
|
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Titers for Serum HI Antibodies
Tidsram: At Day 42
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Tidsram: At Day 42
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A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Tidsram: At Day 42
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Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibody Titers
Tidsram: At Day 42
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Antal ämnen med alla och grad 3 efterfrågade lokala symtom
Tidsram: Under 7-dagarsperioden (dagar 0-6) efter vaccination efter varje dos och över doser
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Bedömda begärda lokala symtom var smärta, rodnad och svullnad.
Alla = förekomst av symtom oavsett intensitetsgrad.
Grad 3 smärta = smärta som förhindrade normal aktivitet.
Grad 3 rodnad/svullnad = rodnad/svullnad som sprider sig över 50 millimeter (mm) från injektionsstället.
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Under 7-dagarsperioden (dagar 0-6) efter vaccination efter varje dos och över doser
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Tidsram: At Days 0, 21, 42 and at Month 12
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Titers for Serum HI Antibodies
Tidsram: At Days 0, 21, 42 and at Month 12
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Tidsram: At Days 21, 42 and at Month 12
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A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Seroprotected Subjects in Terms of HI Antibodies
Tidsram: At Days 0, 21, 42 and at Month 12
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Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Seroconversion Factor (SCF) for HI Antibody Titers
Tidsram: At Days 21, 42 and at Month 12
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Tidsram: At Days 0, 21 and 42
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The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Days 0, 21 and 42
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Titers for Serum Neutralizing Antibodies
Tidsram: At Days 0, 21 and 42
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
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At Days 0, 21 and 42
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Tidsram: At Month 12
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The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Month 12
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Titers for Serum Neutralizing Antibodies
Tidsram: At Month 12
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was Flu A/Neth/602/09.
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At Month 12
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Tidsram: At Days 21 and 42
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A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Days 21 and 42
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Tidsram: At Month 12
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A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Month 12
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsram: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 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
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsram: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 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
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Number of Subjects With Any Medically-attended Events (MAEs)
Tidsram: During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Tidsram: During the entire study period (from Day 0 up to Month 12)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Normal or Abnormal Biochemical Levels
Tidsram: At Days 0, 21 and 42
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Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN].
Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
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At Days 0, 21 and 42
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsram: During the 21-day (Days 0-20) follow-up period after the first vaccination
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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.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 21-day (Days 0-20) follow-up period after the first vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsram: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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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.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsram: During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
- Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
10 september 2009
Primärt slutförande (Faktisk)
27 november 2010
Avslutad studie (Faktisk)
27 november 2010
Studieregistreringsdatum
Först inskickad
20 augusti 2009
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2009
Första postat (Uppskatta)
24 augusti 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 februari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 juli 2017
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 113528
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Statistisk analysplan
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 113528Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .