NCT01839175

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 46 Days – 76 Days
• Healthy volunteers: Accepted

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 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.

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 to MenC * To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine * To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine Booster Secondary objectives * To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose) * To describe the safety 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.

Conditions

• Neisseria Meningitidis
• Bacterial Infections
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Hexavalent vaccine	0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
BIOLOGICAL	NeisVac-C	0.5 mL intramuscular injection at 2 and 4 months of age
BIOLOGICAL	Prevenar 13	0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
BIOLOGICAL	RotaTeq	2 mL oral administration at 2, 3 and 4 months
BIOLOGICAL	Nimenrix	0.5 mL intramuscular injection at 12 months
BIOLOGICAL	M-M-RVAXPRO	0.5 mL intramuscular or subcutaneous injection at 13 months of age

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2015-02-01
• First posted: 2013-04-24
• Last updated: 2017-09-11

Locations

11 sites across 1 country: Finland