CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 284 enrolled
Drug / intervention
V419 +5 morebiological
Likely dose
V419 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01553279
NCT01553279Phase 3Completed
CompareCT.gov

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

MCM Vaccines B.V.·interventional·Posted Mar 14, 2012·Updated Mar 28, 2019

In Brief

A Phase 3 clinical trial evaluating V419, PREVNAR 13®, and 4 other interventions for Neisseria Meningitidis and 2 related conditions. Completed, enrolled 284 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeisseria Meningitidis, Bacterial Infections, Virus Diseases
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2012
Enrollment StartMar 30, 2012
Primary CompletionSep 27, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.3 years ago

Interventions

V419biological

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.

PREVNAR 13®biological

Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

MCC-TTbiological

Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

MCC-CRMbiological

Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

Hib-MCCbiological

Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

MMR Vaccinebiological

Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).