Phase 3 N=7,504 Randomized Double-blind Prevention

Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

Vomiting · Diarrhea · Fever

Bottom Line

View on ClinicalTrials.gov: NCT00362648 ↗

Enrolled (actual)

7,504

Serious AEs

4.0%

Results posted

May 2010

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent (Biological); Comparator: Placebo (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Mar 2009

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	—

Summary

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

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

View full record on ClinicalTrials.gov →

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.