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Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

NCT01926015 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2018-11-14

Study results available
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Summary

The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.

Conditions

  • Rotavirus Disease

Interventions

BIOLOGICAL

RotaTeq™ (V260)

Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains

BIOLOGICAL

DTP-IPV

Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-19
Primary Completion
2014-06-06
Completion
2014-06-06

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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 NCT01926015 on ClinicalTrials.gov