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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
  Purpose

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®.

Condition Intervention Phase
Meningitis, Meningococcal
Rotavirus Infections
 Biological: RotaTeq®
Biological: NeisVac-C®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Seroprotection response for the meningococcal Group C serotype

Enrollment: 246
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   42 Days to 56 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443846

Locations
Finland
Espoo, Finland
Helsinki, Finland
Järvenpää, Finland
Oulu, Finland
Pori, Finland
Tampere, Finland
Turku, Finland
Vantaa, Finland
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00443846     History of Changes
Other Study ID Numbers: S06-ROT-304
Study First Received: March 5, 2007
Last Updated: April 3, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Sanofi Pasteur MSD:
Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Rotavirus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
 Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013