Consistency Lots Vaccine Study (V260-009)

Merck Sharp & Dohme LLC793 enrolled

Overview

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

793

Conditions

Rotavirus Infections

Interventions

rotavirus vaccine, live, oral, pentavalentBIOLOGICAL

Three oral doses (\~8.81 X 10\^7 IU/Dose for Lot 1; \~8.01 X 10\^7 IU/Dose for Lot 2; and \~6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

PlaceboBIOLOGICAL

Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

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 the 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

Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]

Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]

Time frame: 42 days following the 3rd vaccination

Data from ClinicalTrials.gov

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