- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Gruppo 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)
Altri nomi:
Three-dose intramuscular injection (Canada only)
|
|
Sperimentale: 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)
Altri nomi:
Three-dose intramuscular injection (Canada only)
|
|
Sperimentale: 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)
Altri nomi:
Three-dose intramuscular injection (Canada only)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Proportion of subjects with vaccine take
Lasso di tempo: Two months after the second dose
|
Two months after the second dose
|
|
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Occurrence of each type of solicited symptoms
Lasso di tempo: 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.
Lasso di tempo: Within 42 days after dose 1 and dose 2
|
Within 42 days after dose 1 and dose 2
|
|
Occurrence of serious adverse events
Lasso di tempo: Throughout the entire study period
|
Throughout the entire study period
|
|
Serum rotavirus immunoglobulin A (IgA) antibody titers
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: Two months after dose 2.
|
Two months after dose 2.
|
|
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 444563/005
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
-
Specifica del set di dati
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocollo di studio
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Set di dati del singolo partecipante
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Rapporto di studio clinico
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di consenso informato
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Piano di analisi statistica
Identificatore informazioni: 444563/005Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .