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COMPLETEDPHASE3

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

NCT00443846•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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®.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy infants, aged from 6 weeks through full 7 weeks,
•Consent form signed by at least one parent or by the legal representative properly informed about the study,
•Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria

•History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
•Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
•Known or suspected impairment of immunological function,
•Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
•Prior administration of any rotavirus vaccine,
•Prior administration of any vaccine within the 28 days prior to randomisation,
•Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
•History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
•Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
•Clinical evidence of active gastrointestinal illness,
+3 more criteria

Key Dates

Start Date

February 13, 2007

Primary Completion Date

September 4, 2007

Completion Date

October 23, 2007

Last Updated

June 20, 2018

Enrollment

247

ACTUAL participants

Conditions

Meningitis, MeningococcalRotavirus Infections

Interventions

RotaTeq®

BIOLOGICAL

NeisVac-C®

BIOLOGICAL

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

NCT06962904

Rotavirus Infections

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ACTIVE_NOT_RECRUITINGPHASE3

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

NCT05252715

Meningitis, Meningococcal

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TERMINATEDNA

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study