- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00729001
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.
Přehled studie
Postavení
Podmínky
Detailní popis
All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).
The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.
Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
- Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
- Use of antibiotics within 7 days preceding dose 1.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrollment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Household contact with an immunosuppressed individual or pregnant women.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of rotavirus gastroenteritis.
- Inability to contact parents/guardians of the subject by telephone.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: Skupina C
|
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Ostatní jména:
Three-dose intramuscular injection (Canada only)
|
Experimentální: Group A
Human Rotavirus Vaccine - Formulation 1
|
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Ostatní jména:
Three-dose intramuscular injection (Canada only)
|
Experimentální: Group B
Human Rotavirus Vaccine - Formulation 2
|
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Ostatní jména:
Three-dose intramuscular injection (Canada only)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Proportion of subjects with vaccine take
Časové okno: Two months after the second dose
|
Two months after the second dose
|
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Časové okno: Within the 15-day solicited follow-up period after any dose of study vaccine.
|
Within the 15-day solicited follow-up period after any dose of study vaccine.
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Occurrence of each type of solicited symptoms
Časové okno: Within the 15-day solicited follow-up period after any dose of study vaccine
|
Within the 15-day solicited follow-up period after any dose of study vaccine
|
Occurrence of unsolicited symptoms according to WHO classification.
Časové okno: Within 42 days after dose 1 and dose 2
|
Within 42 days after dose 1 and dose 2
|
Occurrence of serious adverse events
Časové okno: Throughout the entire study period
|
Throughout the entire study period
|
Serum rotavirus immunoglobulin A (IgA) antibody titers
Časové okno: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
|
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
|
Rotavirus seropositivity status
Časové okno: Before dose 1 and at the end of the study
|
Before dose 1 and at the end of the study
|
Vaccine take (for pilot efficacy subset only)
Časové okno: 2 months after dose 1
|
2 months after dose 1
|
Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations
Časové okno: Two months after dose 2 and at the end of the study.
|
Two months after dose 2 and at the end of the study.
|
Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Časové okno: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
|
Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
|
Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.
Časové okno: Two months after dose 2 and at the end of the study.
|
Two months after dose 2 and at the end of the study.
|
Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.
Časové okno: Two months after dose 2 and at the end of the study.
|
Two months after dose 2 and at the end of the study.
|
Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants
Časové okno: Two months after dose 2.
|
Two months after dose 2.
|
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Časové okno: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
|
Two weeks after dose 2 until the end of the rotavirus season following vaccination.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1.
- Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 444563/005
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Studijní data/dokumenty
-
Specifikace datové sady
Identifikátor informace: 444563/005Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Protokol studie
Identifikátor informace: 444563/005Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Soubor dat jednotlivých účastníků
Identifikátor informace: 444563/005Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 444563/005Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 444563/005Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Plán statistické analýzy
Identifikátor informace: 444563/005Komentáře 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 .
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