Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
- Conditions
- Neisseria MeningitidisBacterial InfectionsVirus Diseases
- Interventions
- Biological: Hexavalent vaccineBiological: NeisVac-CBiological: RotaTeqBiological: Prevenar 13Biological: NimenrixBiological: M-M-RVAXPRO
- Registration Number
- NCT01839175
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Hexavalent vaccine - Group 2 RotaTeq - Group 2 M-M-RVAXPRO - Group 1 RotaTeq - Group 2 Hexavalent vaccine - Group 2 Nimenrix - Group 1 M-M-RVAXPRO - Group 1 NeisVac-C - Group 1 Prevenar 13 - Group 1 Nimenrix - Group 2 Prevenar 13 -
- Primary Outcome Measures
Name Time Method Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine) Proportion of subjects with an anti-MenC titre ≥1:8 dil Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (11)
Sanofi Pasteur MSD Investigational Site 003
🇫🇮Espoo, Finland
Sanofi Pasteur MSD Investigational Site 001
🇫🇮Helsinki, Finland
Sanofi Pasteur MSD Investigational Site 010
🇫🇮Kokkola, Finland
Sanofi Pasteur MSD Investigational Site 005
🇫🇮Pori, Finland
Sanofi Pasteur MSD Investigational Site 009
🇫🇮Seinajoki, Finland
Sanofi Pasteur MSD Investigational Site 008
🇫🇮Vantaa, Finland
Sanofi Pasteur MSD Investigational Site 002
🇫🇮Helsinki, Finland
Sanofi Pasteur MSD Investigational Site 004
🇫🇮Oulu, Finland
Sanofi Pasteur MSD Investigational Site 007
🇫🇮Turku, Finland
Sanofi Pasteur MSD Investigational Site 011
🇫🇮Jarvenpaa, Finland
Sanofi Pasteur MSD Investigational Site 006
🇫🇮Tampere, Finland