Phase 3
Completed N=762
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
Source: ClinicalTrials.gov NCT00718237 ↗Enrolled (actual)
762
Serious AEs
2.1%
Results posted
Jul 2010
Primary outcomePrimary: Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A — 7; 27 Number of participants — p=<0.001
Summary
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A |
7; 27 | <0.001 sig |
| SECONDARY Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A |
5; 25 | <0.001 sig |
| SECONDARY Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A |
0; 10 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age
Exclusion Criteria
- History Of Known Prior Rotavirus Gastroenteritis
- Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
Data sourced from ClinicalTrials.gov (NCT00718237). 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.