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Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

NCT02062385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4040

Last updated 2018-11-27

Study results available
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Summary

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

V260

V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

BIOLOGICAL

Placebo to V260

Placebo control

BIOLOGICAL

OPV

Oral poliovirus vaccine administered according to the standard of care

BIOLOGICAL

DTaP

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-30
Primary Completion
2015-06-11
Completion
2015-06-11

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062385 on ClinicalTrials.gov