NCT00443846

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

An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 42 Days – 55 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2007-02-13
• Primary completion: 2007-09-04
• Completion: 2007-10-23
• First posted: 2007-03-06
• Last updated: 2018-06-20
• Results posted: 2018-06-20

Regulatory

• FDA-regulated drug study