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

NCT00443846 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V260-016S06-ROT-3042006-005445-11
• Study Type: interventional
• Target: 247
• Locations: 0 countries
• Sites: N/A

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®.

Conditions

Meningitis, Meningococcal; Rotavirus Infections

Keywords

Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype

  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)

Study Arms (2)

Group 1: Concomitant Administration

EXPERIMENTAL

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®; Biological: NeisVac-C®

Group 2: Sequential Administration

ACTIVE COMPARATOR

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®; Biological: NeisVac-C®

Interventions

RotaTeq® BIOLOGICAL

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

Also known as: V260

Group 1: Concomitant Administration; Group 2: Sequential Administration

NeisVac-C® BIOLOGICAL

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

Group 1: Concomitant Administration; Group 2: Sequential Administration

Eligibility Criteria

• Age: 42 Days - 55 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Vesikari T, Karvonen A, Borrow R, Kitchin N, Baudin M, Thomas S, Fiquet A. Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine. Clin Vaccine Immunol. 2011 May;18(5):878-84. doi: 10.1128/CVI.00437-10. Epub 2011 Mar 9.

  PMID: 21389149 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Rotavirus Infections

Interventions

RotaTeq; Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Reoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 6, 2007
• Study Start: February 13, 2007
• Primary Completion: September 4, 2007
• Study Completion: October 23, 2007
• Last Updated: June 20, 2018
• Results First Posted: June 20, 2018

Record last verified: 2017-09