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

NCT01553279 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2019-03-28

Study results available
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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

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 & Collaborators

  • MCM Vaccines B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
46 Days
Max Age
74 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-30
Primary Completion
2013-09-27
Completion
2013-09-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01553279 on ClinicalTrials.gov