Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
28. mai 2018 oppdatert av: GlaxoSmithKline
A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus.
Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines.
Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.
This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study has 2 phases:
The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.
The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Studietype
Intervensjonell
Registrering (Faktiske)
5075
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ekaterinburg, Den russiske føderasjonen, 620078
- GSK Investigational Site
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Ekaterinburg, Den russiske føderasjonen, 620028
- GSK Investigational Site
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Kazan, Den russiske føderasjonen, 420015
- GSK Investigational Site
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Novokuznetsk, Den russiske føderasjonen, 654063
- GSK Investigational Site
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Saratov, Den russiske føderasjonen
- GSK Investigational Site
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Tallinn, Estland, 10617
- GSK Investigational Site
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Tartu, Estland, 50417
- GSK Investigational Site
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Caen cedex 4, Frankrike, 14052
- GSK Investigational Site
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Lagord, Frankrike, 17140
- GSK Investigational Site
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Nantes, Frankrike, 44093
- GSK Investigational Site
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Paris Cedex 18, Frankrike, 75877
- GSK Investigational Site
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Poitiers, Frankrike, 86000
- GSK Investigational Site
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Rouen, Frankrike, 76100
- GSK Investigational Site
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Rotterdam, Nederland, 3011 EN
- GSK Investigational Site
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Rotterdam, Nederland, 3015 GE
- GSK Investigational Site
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Barcelona, Spania, 08036
- GSK Investigational Site
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Barcelona, Spania, 08035
- GSK Investigational Site
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Madrid, Spania, 28041
- GSK Investigational Site
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Madrid, Spania, 28006
- GSK Investigational Site
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Madrid, Spania, 28040
- GSK Investigational Site
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Marid, Spania, 28040
- GSK Investigational Site
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Valencia, Spania, 46017
- GSK Investigational Site
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Valencia, Spania, 46014
- GSK Investigational Site
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Eskilstuna, Sverige, SE-631 88
- GSK Investigational Site
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Stockholm, Sverige, SE-141 86
- GSK Investigational Site
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Berlin, Tyskland, 14057
- GSK Investigational Site
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Berlin, Tyskland, 10117
- GSK Investigational Site
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Berlin, Tyskland, 10787
- GSK Investigational Site
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Hamburg, Tyskland, 22143
- GSK Investigational Site
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Hamburg, Tyskland, 20249
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Tyskland, 81667
- GSK Investigational Site
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Muenchen, Bayern, Tyskland, 80799
- GSK Investigational Site
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Regensburg, Bayern, Tyskland, 93053
- GSK Investigational Site
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Wuerzburg, Bayern, Tyskland, 97070
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Schwerin, Mecklenburg-Vorpommern, Tyskland, 19055
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Tyskland, 30519
- GSK Investigational Site
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Nordrhein-Westfalen
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Witten, Nordrhein-Westfalen, Tyskland, 58455
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01067
- GSK Investigational Site
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Leipzig, Sachsen, Tyskland, 04229
- GSK Investigational Site
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Leipzig, Sachsen, Tyskland, 04103
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
- Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
- Lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: GSK1562902A Group
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
The group was further stratified by age for analyses.
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2 doses, intramuscular injection
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Aktiv komparator: Fluarix+Placebo Group
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
The group was further stratified by age for analyses.
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One intramuscular injection
One intramuscular injection
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Subjects With Solicited Local Symptoms
Tidsramme: During a 7 day follow-up period after each dose of vaccine and overall.
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Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling.
Any = occurrence of symptom regardless of intensity grade.
Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
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During a 7 day follow-up period after each dose of vaccine and overall.
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Number of Subjects With Solicited General Symptoms (Dose 1)
Tidsramme: During the 7-day (Days 0-6) after Dose 1
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) after Dose 1
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Number of Subjects With Solicited General Symptoms (Dose 2)
Tidsramme: During the 7-day (Days 0-6) after Dose 2
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) after Dose 2
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Number of Subjects With Solicited General Symptoms (Across Doses)
Tidsramme: During the 7-day (Days 0-6) post vaccination across dosses
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating.
Any = occurrence of symptom regardless of intensity grade and relationship to vaccination.
Grade 3 symptom = symptoms that prevented normal activity.
Grade 3 Fever = fever higher than (>) 39.0 °C.
Related = symptom considered by the investigator to be casually related with the study vaccination.
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During the 7-day (Days 0-6) post vaccination across dosses
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Number of Subjects With Unsolicited Adverse Events (AEs)
Tidsramme: During the 21st Day (Days 0-20) post Dose 1
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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.
Related symptoms were not available.
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During the 21st Day (Days 0-20) post Dose 1
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Number of Subjects With AEs
Tidsramme: During the 30 Day (Days 0-29) post Dose 2
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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.
Related symptoms were not available.
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During the 30 Day (Days 0-29) post Dose 2
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: From Day 0 to Day 180
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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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From Day 0 to Day 180
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Number of Subjects With New Onset Chronic Diseases (NOCDs)
Tidsramme: From Day 0 to Day 180
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NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
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From Day 0 to Day 180
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Number of Subjects With Medically Significant Conditions (MSCs)
Tidsramme: From Day 0 to Day 51
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MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits.
Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
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From Day 0 to Day 51
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Tidsramme: At Day 0 (PRE), 21 and 42
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Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
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At Day 0 (PRE), 21 and 42
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Number of Seroconverted Subjects Against H5N1
Tidsramme: At Day 21 and Day 42
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Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer.
Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
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At Day 21 and Day 42
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Tidsramme: At Day 21 and Day 42
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
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At Day 21 and Day 42
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Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Tidsramme: At Day 0 (PRE), Day 21 and Day 42
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Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
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At Day 0 (PRE), Day 21 and Day 42
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2006
Primær fullføring (Faktiske)
1. januar 2007
Studiet fullført (Faktiske)
31. juli 2007
Datoer for studieregistrering
Først innsendt
26. april 2006
Først innsendt som oppfylte QC-kriteriene
26. april 2006
Først lagt ut (Anslag)
27. april 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2018
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 107064
- 107217 (Annen identifikator: GSK)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Skjema for informert samtykke
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
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Statistisk analyseplan
Informasjonsidentifikator: 107064Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .