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

Phase 3

Completed

• Conditions: Meningitis, Meningococcal; Rotavirus Infections
• Interventions: Biological: RotaTeq®; Biological: NeisVac-C®

• Registration Number: NCT00443846
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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®.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-02-13
• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Primary Completion: 2007-09-04
• Study Completion: 2007-10-23
• Status Verified: 2017-09
• Results First Submitted: 2017-09-08
• Results First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Results First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Sequential Administration	RotaTeq®	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.
Group 2: Sequential Administration	NeisVac-C®	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.
Group 1: Concomitant Administration	RotaTeq®	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).
Group 1: Concomitant Administration	NeisVac-C®	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype	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.