Immunogenicity and Safety of V419 Given at 2, 3 and 4 Months of Age With Meningococcal Serogroup C Conjugate Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01553279
First received: March 7, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

Primary objective

• To evaluate the concomitant administration of PR5I with two types of MCC vaccines (MCC-TT and MCC-CRM)

Secondary objectives

Part I

  • To describe the immunogenicity of PR5I when PR5I is given at 2 months of age and concomitantly with MCC vaccines at 3 and 4 months of age
  • To describe the immunogenicity of MCC vaccines when MCC vaccines are given concomitantly with PR5I at 3 and 4 months of age (post-dose 1 and post-dose 2)
  • To describe the safety of PR5I given concomitantly with PCV-13 and MCC vaccines

Part II

• To describe the immunogenicity and safety of Hib-MCC when given at 12 months of age in subjects who have received PR5I at 2, 3 and 4 months of age


Condition Intervention Phase
Neisseria Meningitidis
Bacterial Infections
Virus Diseases
Biological: V419 (PR5I)
Biological: Prevenar 13
Biological: NeisVac-C
Biological: MENJUGATE
Biological: MENITORIX
Biological: M-M-RVAXPRO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Meningococcal serogroup C seroprotection rate [ Time Frame: 1 month post-dose 2 of MCC vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polyribosylribitol phosphate (PRP) seroprotection rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Hepatitis B seroprotection rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Diphtheria seroprotection rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Tetanus seroprotection rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Polio type 1, 2 and 3 seroprotection rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Pertussis seroresponse rate [ Time Frame: 1 month post-dose 3 of PR5I vaccine ] [ Designated as safety issue: No ]
  • Meningococcal serogroup C seroprotection rate [ Time Frame: 1 month post-dose 1 of MCC vaccine ] [ Designated as safety issue: No ]
  • Solicited injection-site reactions and systemic adverse events [ Time Frame: From Day 1 to Day 5 following each PR5I vaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited injection-site reactions and systemic adverse events [ Time Frame: From Day 1 to Day 15 following each PR5I vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of 11 months ] [ Designated as safety issue: Yes ]

Enrollment: 284
Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: PR5I and MCC-TT Biological: V419 (PR5I)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b conjugate [Meningococcal Outer Membrane Protein Complex], and hepatitis B [Recombinant] Vaccine 0.5 mL intramuscular injection at 2, 3 and 4 months of age
Biological: Prevenar 13
Pneumococcal conjugate vaccine (13-valent, adsorbed) 0.5 mL intramuscular injection at 2 and 4 months of age
Biological: NeisVac-C
Meningococcal group C polysaccharide conjugate vaccine adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
Biological: MENITORIX
Haemophilus type b and meningococcal group C conjugate vaccine 0.5 mL intramuscular injection at 12 months of age
Biological: M-M-RVAXPRO
Measles, mumps, and rubella vaccine (live)
Experimental: Group 2: PR5I and MCC-CRM Biological: V419 (PR5I)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b conjugate [Meningococcal Outer Membrane Protein Complex], and hepatitis B [Recombinant] Vaccine 0.5 mL intramuscular injection at 2, 3 and 4 months of age
Biological: Prevenar 13
Pneumococcal conjugate vaccine (13-valent, adsorbed) 0.5 mL intramuscular injection at 2 and 4 months of age
Biological: MENJUGATE
Meningococcal group C conjugate vaccine adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
Biological: MENITORIX
Haemophilus type b and meningococcal group C conjugate vaccine 0.5 mL intramuscular injection at 12 months of age
Biological: M-M-RVAXPRO
Measles, mumps, and rubella vaccine (live)

  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:

  • Subject participating in a study with an investigational compound or device since birth
  • History of congenital or acquired immunodeficiency
  • History of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
  • Chronic illness that could interfere with study conduct or completion
  • 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
  • History or mother history of HBsAg seropositivity
  • Coagulation disorder that contraindicate intramuscular injection
  • 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)
  • History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
  • Receipt of immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
  • 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
  • Antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
  • Febrile illness or body temperature ≥38.0°C in the last 24 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553279

Locations
United Kingdom
Sanofi Pasteur MSD Investigational Site 006
Bath, United Kingdom
Sanofi Pasteur MSD Investigational Site 001
Bristol, United Kingdom
Sanofi Pasteur MSD Investigational Site 007
Exeter, United Kingdom
Sanofi Pasteur MSD Investigational Site 010
Gloucester, United Kingdom
Sanofi Pasteur MSD Investigational Site 004
London, United Kingdom
Sanofi Pasteur MSD Investigational Site 011
Manchester, United Kingdom
Sanofi Pasteur MSD Investigational Site 002
Oxford, United Kingdom
Sanofi Pasteur MSD Investigational Site 005
Southampton, United Kingdom
Sanofi Pasteur MSD Investigational Site 008
Taunton, United Kingdom
Sanofi Pasteur MSD Investigational Site 009
Truro, United Kingdom
Sanofi Pasteur MSD Investigational Site 003
Yeovil, United Kingdom
Sponsors and Collaborators
Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01553279     History of Changes
Other Study ID Numbers: PRI01C, 2011-002413-11
Study First Received: March 7, 2012
Last Updated: March 18, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014