Status:
COMPLETED
Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Neisseria Meningitidis
Bacterial Infections
Eligibility:
All Genders
46-76 years
Phase:
PHASE3
Brief Summary
Primary Series Primary objectives * To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administrati...
Detailed Description
Primary Series Secondary objectives * To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not...
Eligibility Criteria
Inclusion
- Healthy infant 46 to 74 days of age (both inclusive)
- Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
- Subject's parent(s) or legal representative able to comply with the study procedures
Exclusion
- Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding each study vaccination
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
- Know or suspected congenital, hereditary or acquired immunodeficiency
- History of seizures or encephalopathy
- Known thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- Chronic illness that could interfere with trial conduct or completion
- Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines
- Contraindication to any of the study vaccines
- Known personal or maternal history of hepatitis B or hepatitis C seropositivity
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
- Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth
- Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01839175
Start Date
April 1 2013
End Date
February 1 2015
Last Update
September 11 2017
Active Locations (11)
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1
Sanofi Pasteur MSD Investigational Site 003
Espoo, Finland
2
Sanofi Pasteur MSD Investigational Site 001
Helsinki, Finland
3
Sanofi Pasteur MSD Investigational Site 002
Helsinki, Finland
4
Sanofi Pasteur MSD Investigational Site 011
Jarvenpaa, Finland