Study

Overview

Official Title: 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

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 Type:

Interventional

Study Phase:

Phase 3

Enrollment:

284

Study Start Date:

March 2012

Study Completion Date:

September 2013

Primary Completion Date:

September 2013

Eligibility

Ages Eligible for Study:

46 days to 74 days

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

CRITERIA

Inclusion Criteria:

Healthy infant 46 to 74 days of age (both inclusive)
Parent(s)/legal representative able to comply will the study procedures

Exclusion Criteria:

Is participating in a study with an investigational compound or device since birth
Has a history of congenital or acquired immunodeficiency
Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
Has a chronic illness that could interfere with study conduct or completion
Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
Has a coagulation disorder that contraindicate intramuscular injection
Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
Has a febrile illness or body temperature ≥38.0°C in the last 24 hours

Locations

No Contacts or Locations in US/Canada Provided

Results

Click here to access ClinicalTrials.gov site to view results.

Clinical Study Reports

Synopsis V419-011

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results