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RotaTeq® and Meningococcus C Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00443846
First received: March 5, 2007
Last updated: April 3, 2009
Last verified: April 2009
History of Changes

March 5, 2007
April 3, 2009
February 2007
April 2008   (final data collection date for primary outcome measure)
Seroprotection response for the meningococcal Group C serotype
Same as current
Complete list of historical versions of study NCT00443846 on ClinicalTrials.gov Archive Site
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RotaTeq® and Meningococcus C Vaccine in Healthy Infants
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.

Secondary objectives:

  • Efficacy: Additional immunogenicity assessments.
  • Safety: To describe the safety profile of RotaTeq® and of the MCC vaccine when administered concomitantly with RotaTeq®.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningitis, Meningococcal
  • Rotavirus Infections
  • Biological: RotaTeq®
  • Biological: NeisVac-C®
Not Provided
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. Epub 2011 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
42 Days to 56 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00443846
S06-ROT-304
Not Provided
Anne FIQUET MD, Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Study Director: Anne FIQUET, MD SPMSD
Sanofi Pasteur MSD
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP