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

Merck Sharp & Dohme LLC7,504 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

7,504

Conditions

Vomiting Diarrhea Fever

Interventions

RotaTeq™ - Rotavirus Vaccine, Live, Oral, PentavalentBIOLOGICAL

2.0 mL oral dose of RotaTeq™. 14 week treatment period

Comparator: PlaceboBIOLOGICAL

Arm 2: Placebo. 14 week treatment period

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose

Time frame: At least 14 days following the third vaccination

Secondary Outcomes

Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

Time frame: 14 days following the 3rd vaccination

Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

Time frame: 14 days following the 3rd vaccination

Data from ClinicalTrials.gov

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