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

September 8, 2017 updated by: Merck Sharp & Dohme LLC

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,
  • Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
  • Infants residing in a household with an immunocompromised person,
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Concomitant Administration
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).
Biological: RotaTeq®
Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
Other Names:
  • V260
Biological: NeisVac-C®
Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
Active Comparator: Group 2: Sequential Administration
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
Biological: RotaTeq®
Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
Other Names:
  • V260
Biological: NeisVac-C®
Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
Time Frame: 28 days after the second dose of MCC vaccine (approximately 20 weeks)
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.
28 days after the second dose of MCC vaccine (approximately 20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2007

Primary Completion (Actual)

September 4, 2007

Study Completion (Actual)

October 23, 2007

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V260-016
  • S06-ROT-304 (Other Identifier: MCMVaccBV (SPMSD) Protocol Number)
  • 2006-005445-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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