Phase 3 N=1,312 Randomized Double-blind Prevention

Dose Confirmation Efficacy Study (V260-007)

Rotavirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT00092443 ↗

Enrolled (actual)

1,312

Serious AEs

3.8%

Results posted

Jul 2009

Primary outcome: 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 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: RotaTeq™, rotavirus vaccine, live, oral, pentavalent (Biological); Comparator: Placebo matching RotaTeq™ (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2004

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	—

Summary

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

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

View full record on ClinicalTrials.gov →

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.