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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
529
Proportion of subjects with vaccine take
Time frame: Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Time frame: Within the 15-day solicited follow-up period after any dose of study vaccine.
Occurrence of each type of solicited symptoms
Time frame: Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Time frame: Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Time frame: Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
Time frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Time frame: Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
Time frame: 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
Time frame: 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
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Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (Canada only)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Two months after dose 2.
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Time frame: Two weeks after dose 2 until the end of the rotavirus season following vaccination.