Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
31. července 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
210
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bilbao, Španělsko, 48013
- GSK Investigational Site
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Burgos, Španělsko, 09005
- GSK Investigational Site
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Madrid, Španělsko, 28046
- GSK Investigational Site
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Móstoles/Madrid, Španělsko, 28935
- GSK Investigational Site
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Sevilla, Španělsko, 41013
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
3 roky až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Skupina A
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Two primary intramuscular (IM) injections and a booster IM injection
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Počet subjektů s vyžádanými lokálními příznaky a 3. stupně
Časové okno: Během 7denního (dny 0-6) po vakcinaci po každé dávce a napříč dávkami
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Vyhodnocenými požadovanými místními příznaky byly bolest, zarudnutí a otok.
Jakýkoli = výskyt příznaku bez ohledu na stupeň intenzity.
Bolest 3. stupně = bolest, která bránila normální aktivitě.
Zarudnutí/otok 3. stupně = zarudnutí/otok šířící se za 50 milimetrů (mm) místa vpichu.
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Během 7denního (dny 0-6) po vakcinaci po každé dávce a napříč dávkami
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
10. září 2009
Primární dokončení (Aktuální)
27. listopadu 2010
Dokončení studie (Aktuální)
27. listopadu 2010
Termíny zápisu do studia
První předloženo
20. srpna 2009
První předloženo, které splnilo kritéria kontroly kvality
20. srpna 2009
První zveřejněno (Odhad)
24. srpna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. února 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. července 2017
Naposledy ověřeno
1. října 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 113528
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
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Plán statistické analýzy
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář komentované zprávy o případu
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Soubor dat jednotlivých účastníků
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Protokol studie
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifikace datové sady
Identifikátor informace: 113528Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .