Phase 3 N=69,274 Randomized Double-blind Prevention

Rotavirus Efficacy and Safety Trial (REST)(V260-006)

Rotavirus Infections

Bottom Line

View on ClinicalTrials.gov: NCT00090233 ↗

Enrolled (actual)

69,274

Serious AEs

2.6%

Results posted

May 2011

Primary outcome: Primary: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo — 6; 5 Participants — p=0.006

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rotateq™ (Biological); Comparator: Placebo (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo	6; 5	0.006 sig
PRIMARY Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination	82; 315	<0.001 sig
SECONDARY G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus	95; 8	<0.001 sig
SECONDARY Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4	6; 144; 14; 213	<0.001 sig
SECONDARY Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.	48; 262; 49; 265	<0.001 sig
SECONDARY Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose	1; 51; 1; 51	<0.001 sig
SECONDARY Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo	197; 203; 417; 426; 136; 142	<0.001 sig
SECONDARY Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin	20.18; 22.73; 55.69; 64.33; 34.77; 59.17	<0.001 sig
SECONDARY Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F	1.13; 0.96; 2.39; 1.72; 1.90; 1.78	<0.001 sig

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

None Specified

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090233). 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.