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

NCT ID: NCT00443846

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-13
• Study Completion Date: 2007-10-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

RotaTeq®

Intervention Type: BIOLOGICAL

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

NeisVac-C®

Intervention Type: BIOLOGICAL

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

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.

Group Type: ACTIVE_COMPARATOR

RotaTeq®

Intervention Type: BIOLOGICAL

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

NeisVac-C®

Intervention Type: BIOLOGICAL

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

Interventions

RotaTeq®

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

Intervention Type: BIOLOGICAL

NeisVac-C®

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

Intervention Type: BIOLOGICAL

Other Intervention Names

V260

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 55 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 21389149 (View on PubMed)

Other Identifiers

S06-ROT-304

Identifier Type: OTHER

Identifier Source: secondary_id

2006-005445-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V260-016

Identifier Type: -

Identifier Source: org_study_id