Phase 3
Completed N=1,312
Dose Confirmation Efficacy Study (V260-007)
Rotavirus Infections
Source: ClinicalTrials.gov NCT00092443 ↗
Enrolled (actual)
1,312
Serious AEs
3.8%
Results posted
Jul 2009
Primary outcomePrimary: Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. — 15; 54 Participants — p=<0.001
Summary
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. |
15; 54 | <0.001 sig |
| SECONDARY Number of Subjects With ≥3 Fold Rise in Antibody Titer |
38; 9; 6; 25; 15; 2 | — |
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 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 (NCT00092443). 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.