A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) given at 2, 3, and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age

Sanofi Pasteur MSD0 sites350 target enrollmentJanuary 29, 2013

Overview

No summary available.

Registry

who.int

Start Date

January 29, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur MSD

•PRIMARY SERIES:
•1\. Healthy infant 46 to 74 days of age (both inclusive)
•2\. Born at full term of pregnancy (\=37 weeks) and/or with a birth weight\=2\.5 kg
•3\. Informed consent signed by the subject's parent(s) or legal representative
•4\. Subject's parent(s) or legal representative able to comply with the study procedures
•such as adherence to study visits and completion of the diary cards
•5\. Covered by health insurance
•1\. Infant who received 3 doses of the hexavalent vaccine in the Primary series
•2\. Healthy infant from 12 months of age
•3\. Informed consent signed by the subject's parent(s) or legal representative

•PRIMARY SERIES:
•1\. Participation at the time of study enrolment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
•2\. Receipt of any vaccine in the 4 weeks preceding each study vaccination or planned receipt of a vaccine in the 4 weeks following each study vaccine administration
•3\. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
•4\. Know or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficiency condition
•5\. History of seizures or encephalopathy
•6\. Known thrombocytopenia, as reported by the subject's parent or legal representative
•7\. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
•8\. Chronic illness that, in the opinion of the investigators, is at a stage where it might interfere with trial conduct or completion
•9\. 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