Phase 3
N=793
Consistency Lots Vaccine Study (V260-009)
Rotavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00092456 ↗Enrolled (actual)
793
Serious AEs
1.7%
Results posted
Apr 2011
Primary outcome: Primary: Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] — 167.9; 193.2; 171.0; 9.3 dilution units — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rotavirus vaccine, live, oral, pentavalent (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] |
167.9; 193.2; 171.0; 9.3; 20.7; 22.6 | <0.001 sig |
Summary
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00092456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.