Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 793
- Primary Endpoint
- Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Study Overview
Brief Summary
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy infants
Exclusion Criteria
- •History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- •Known or suspected problems with the immune system
- •Fever at time of immunization
- •Prior administration of a rotavirus vaccine
- •History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
Arms & Interventions
RotaTeq™ Lot 1
~8.81 X 10^7 IU/Dose of RotaTeq™
Intervention: rotavirus vaccine, live, oral, pentavalent (Biological)
RotaTeq™ Lot 2
~8.01 X 10^7 IU/Dose of RotaTeq™
Intervention: rotavirus vaccine, live, oral, pentavalent (Biological)
RotaTeq™ Lot 3
~6.91 X 10^7 IU/Dose of RotaTeq™
Intervention: rotavirus vaccine, live, oral, pentavalent (Biological)
Placebo
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Time Frame: 42 days following the 3rd vaccination
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
Secondary Outcomes
No secondary outcomes reported