Infections, Rotavirus
Conditions
Keywords
Rotavirus Gastroenteritis, Human rotavirus vaccine
Brief summary
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.
Detailed description
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.
Interventions
BIOLOGICALHuman Rotavirus Vaccine - two different formulations
Two oral doses
BIOLOGICALPrevnar
Three-dose intramuscular injection (US subjects only)
BIOLOGICALIPOL
Two-dose intramuscular injection (US subjects only)
BIOLOGICALInfanrix
Three-dose intramuscular injection (US subjects only)
BIOLOGICALOmniHIB
Three-dose intramuscular injection (US subjects only)
BIOLOGICALPentacel
Three-dose intramuscular injection (Canada only)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with vaccine take | Two months after the second dose |
| Occurrence of any grade 2 or 3 fever, vomiting or diarrhea | Within the 15-day solicited follow-up period after any dose of study vaccine. |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of serious adverse events | Throughout the entire study period |
| Serum rotavirus immunoglobulin A (IgA) antibody titers | At visits 1, 3 and 4 and at all Visits for pilot efficacy subset |
| Rotavirus seropositivity status | Before dose 1 and at the end of the study |
| Vaccine take (for pilot efficacy subset only) | 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 | Two months after dose 2 and at the end of the study. |
| Occurrence of each type of solicited symptoms | Within the 15-day solicited follow-up period after any dose of study vaccine |
| Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status. | 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. | 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 | Two months after dose 2. |
| Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects) | Two weeks after dose 2 until the end of the rotavirus season following vaccination. |
| Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F | Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects) |
| Occurrence of unsolicited symptoms according to WHO classification. | Within 42 days after dose 1 and dose 2 |
Outcome results
None listed