NCT00757770CompletedPhase 3
Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 854
- Locations
- 4
- Primary Endpoint
- Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Study Overview
Brief Summary
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Child is unlikely to remain in the study area for the duration of the study.
- •Previous confirmed occurrence of rotavirus gastroenteritis.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •Household contact with an immunosuppressed individual or pregnant woman.
- •Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
- •Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Arms & Interventions
Group Placebo
Active Comparator
Intervention: Placebo (Biological)
Group HRV Lot B
Experimental
Intervention: Rotarix (Biological)
Group HRV Lot C
Experimental
Intervention: Rotarix (Biological)
Group HRV Lot A
Experimental
Intervention: Rotarix (Biological)
Outcomes
Primary Outcomes
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Time Frame: Two months after Dose 2.
Secondary Outcomes
- Vaccine take rates in a subset of subjects.(Two months after each dose)
- Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.(Two months after Dose 1.)
- Presence of rotavirus in stool samples in a subset of subjects(On the day of each vaccination and on planned days following each vaccination.)
- Seroconversion rates to anti-rotavirus IgA antibody(Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).)
- For each type of solicited symptom, occurrence of the symptom(During the 8-day follow-up period after each vaccine dose)
- Occurrence of unsolicited symptoms(During the 31-day follow-up period after each vaccine dose.)
- Occurrence of serious adverse events(Throughout the study period.)
Investigators
Study Sites (4)
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