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RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

NCT00443846 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2018-06-20

Study results available
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Summary

Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

Conditions

  • Meningitis, Meningococcal
  • Rotavirus Infections

Interventions

BIOLOGICAL

RotaTeq®

Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.

BIOLOGICAL

NeisVac-C®

Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
55 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-13
Primary Completion
2007-09-04
Completion
2007-10-23
FDA Drug
Yes

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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 NCT00443846 on ClinicalTrials.gov