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

PHASE3CompletedINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

March 30, 2012

Primary Completion Date

September 27, 2013

Study Completion Date

September 27, 2013

Conditions
Neisseria MeningitidisBacterial InfectionsVirus Diseases
Interventions
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).

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MCM Vaccines B.V.

INDUSTRY

NCT01553279 - Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011) | Biotech Hunter | Biotech Hunter