NCT01553279

Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: MCM Vaccines B.V. · Industry
• Sex: All
• Age: 46 Days – 74 Days
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.

Conditions

• Neisseria Meningitidis
• Bacterial Infections
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	V419	Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.
BIOLOGICAL	PREVNAR 13®	Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).
BIOLOGICAL	MCC-TT	Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
BIOLOGICAL	MCC-CRM	Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
BIOLOGICAL	Hib-MCC	Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.
BIOLOGICAL	MMR Vaccine	Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

Timeline

• Start date: 2012-03-30
• Primary completion: 2013-09-27
• Completion: 2013-09-27
• First posted: 2012-03-14
• Last updated: 2019-03-28
• Results posted: 2019-03-28