Dose Confirmation Efficacy Study (V260-007)

Merck Sharp & Dohme LLC1,312 enrolled

Overview

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

The duration of treatment is 10 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,312

Conditions

Rotavirus Infections

Interventions

RotaTeq™, rotavirus vaccine, live, oral, pentavalentBIOLOGICAL

Three doses of RotaTeq™ administered 28 to 70 days apart.

Comparator: Placebo matching RotaTeq™BIOLOGICAL

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.

G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition

Time frame: At least 14 days following the 3rd vaccination

Secondary Outcomes

Number of Subjects With ≥3 Fold Rise in Antibody Titer

Induction of postdose 3 rotavirus Serum neutralizing antibody (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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