Phase 3
Completed N=7,504
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Source: ClinicalTrials.gov NCT00362648 ↗Enrolled (actual)
7,504
Serious AEs
4.0%
Results posted
May 2010
Primary outcomePrimary: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose — 79; 129; 38; 71 Subjects — p=<0.001
Summary
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose |
79; 129; 38; 71; 2278; 2219 | <0.001 sig |
| SECONDARY Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] |
148; 34; 35; 0; 17; 5 | — |
| SECONDARY Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] |
115; 24; 42; 3; 13; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 4 weeks through 12 weeks at Dose 1
- Parent able to understand study procedures and give consent
Exclusion Criteria
- Clinical evidence of active gastrointestinal disease
- Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Data sourced from ClinicalTrials.gov (NCT00362648). 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. Informational only — not medical advice.