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

NCT01839175 Phase 3 COMPLETED

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 administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine * To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC Booster Primary objectives \- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	350
Start date	2013-04
Completion	2015-02

Conditions

• Neisseria Meningitidis
• Bacterial Infections
• Virus Diseases

Interventions

• Hexavalent vaccine
• NeisVac-C
• Prevenar 13
• RotaTeq
• Nimenrix
• M-M-RVAXPRO

Primary outcomes

• Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL — Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
• Proportion of subjects with an anti-MenC titre ≥1:8 dil — Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)

Countries

Finland