Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Phase 3
Completed
- Conditions
- Infections, Rotavirus
- Registration Number
- NCT00757770
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 854
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs). Two months after Dose 2.
- Secondary Outcome Measures
Name Time Method 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 Vaccine take rates in a subset of subjects. Two months after each 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.
Trial Locations
- Locations (1)
GSK Investigational Site
Location not specified
GSK Investigational Site