Immunogenicity and Safety of V419 Given at 2, 3 and 4 Months of Age With Meningococcal Serogroup C Conjugate Vaccines
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01553279
First received: March 7, 2012
Last updated: April 10, 2013
Last verified: April 2013
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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:
Drug Information available for:
Heptavalent pneumococcal conjugate vaccine
Measles-Mumps-Rubella Vaccine
Pneumococcal Vaccines
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | September 2013 (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
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: | April 10, 2013 |
| 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 May 16, 2013