Clinical trial NCT00443846: RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal
Rotavirus Infections
Keywords: Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 247
Sex: ALL
Minimum age (years): 42
Maximum age (years): 55
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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®.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
timeFrame: 28 days after the second dose of MCC vaccine (approximately 20 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.