NCT01839175CompletedPhase 3
A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age
Sanofi Pasteur, a Sanofi Company11 sites in 1 country350 target enrollmentStarted: April 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 350
- Locations
- 11
- Primary Endpoint
- Proportion of subjects with an anti-MenC titre ≥1:8 dil
Study Overview
Brief Summary
Primary Series Primary objectives
- To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine
- To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC
Booster Primary objectives
- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Detailed Description
Primary Series Secondary objectives
- To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC
- To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine
- To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine
Booster Secondary objectives
- To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose)
- To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 46 Days to 76 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy infant 46 to 74 days of age (both inclusive)
- •Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
- •Subject's parent(s) or legal representative able to comply with the study procedures
Exclusion Criteria
- •Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccine in the 4 weeks preceding each study vaccination
- •Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
- •Know or suspected congenital, hereditary or acquired immunodeficiency
- •History of seizures or encephalopathy
- •Known thrombocytopenia
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- •Chronic illness that could interfere with trial conduct or completion
- •Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines
- •Contraindication to any of the study vaccines
- •Known personal or maternal history of hepatitis B or hepatitis C seropositivity
- •History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
- •Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth
- •Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.
Arms & Interventions
Group 2
Active Comparator
Intervention: Hexavalent vaccine (Biological)
Group 1
Experimental
Intervention: Hexavalent vaccine (Biological)
Group 1
Experimental
Intervention: RotaTeq (Biological)
Group 1
Experimental
Intervention: M-M-RVAXPRO (Biological)
Group 1
Experimental
Intervention: Nimenrix (Biological)
Group 1
Experimental
Intervention: Prevenar 13 (Biological)
Group 1
Experimental
Intervention: NeisVac-C (Biological)
Group 2
Active Comparator
Intervention: M-M-RVAXPRO (Biological)
Group 2
Active Comparator
Intervention: Nimenrix (Biological)
Group 2
Active Comparator
Intervention: RotaTeq (Biological)
Group 2
Active Comparator
Intervention: Prevenar 13 (Biological)
Outcomes
Primary Outcomes
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Time Frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Secondary Outcomes
- Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster))
- Proportion of subjects with an anti-MenC titre ≥1:8 dil(Month 3 (One month after dose 1 of MenC vaccine))
- Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL(Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster))
- Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with pertussis vaccine response(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine))
- Solicited injection-site and systemic reactions(Day 1 to Day 7 following vaccination)
- Unsolicited adverse events(Day 1 to Day 30 following vaccination)
- Serious adverse events(From signature of the informed consent to the last visit of the subject, an expected average of 11 months)
- Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with pertussis booster response(Month 13 (One month post-booster))
- Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil(Month 13 (One month after MenAWCY vaccine))
- Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL(Month 12 (Pre-booster) and Month 13 (One month post-booster))
Investigators
Study Sites (11)
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