A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,274
- Locations
- 3
- Primary Endpoint
- Number of Seroconverted Subjects Against Human Rotavirus
Study Overview
Brief Summary
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
- •Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria
- •se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Household contact with an immunosuppressed individual or pregnant women.
- •Previous confirmed occurrence of RV GE.
Arms & Interventions
Liquid Rotarix Group
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Intervention: Liquid formulation of HRV vaccine (Biological)
Lyophilized Rotarix Group
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Intervention: Lyophilized formulation of HRV vaccine (Biological)
Outcomes
Primary Outcomes
Number of Seroconverted Subjects Against Human Rotavirus
Time Frame: At 1 to 2 months after the second vaccine dose (Months 3-4)
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
Secondary Outcomes
- Concentrations of Anti-rotavirus IgA Antibodies(At 1 to 2 months after the second vaccine dose (Months 3-4))
- Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies(At 1 to 2 months after the second vaccine dose (Months 3-4))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.)
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period (from Day 0 to Month 4))
- Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes(From the first vaccine dose (Dose 1) up to Month 4)