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RotaTeq® and Meningococcus C Vaccine in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00443846
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment Phase
Meningitis, Meningococcal Rotavirus Infections Biological: RotaTeq® Biological: NeisVac-C® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
Concomitant administration
Biological: RotaTeq® Biological: NeisVac-C®
Active Comparator: Group 2
Staggered administration
Biological: RotaTeq® Biological: NeisVac-C®



Primary Outcome Measures :
  1. Seroprotection response for the meningococcal Group C serotype [ Time Frame: 28 to 42 days post vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 56 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443846


Locations
Finland
Espoo, Finland
Helsinki, Finland
Järvenpää, Finland
Oulu, Finland
Pori, Finland
Tampere, Finland
Turku, Finland
Vantaa, Finland
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Anne FIQUET, MD SPMSD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00443846     History of Changes
Other Study ID Numbers: V260-016
S06-ROT-304 ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

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