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

ClinicalTrials.gov Identifier: NCT01553279 (view full study on clinicaltrials.gov)
Condition:  Neisseria meningitidis, Bacterial infections, Virus diseases
Status:  Completed


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
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

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Clinical Study Reports

Synopsis  V419-011


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