Neisseria Meningitidis, Bacterial Infections, Virus Diseases
Conditions
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.
Interventions
BIOLOGICALHexavalent vaccine
0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
BIOLOGICALNeisVac-C
0.5 mL intramuscular injection at 2 and 4 months of age
BIOLOGICALPrevenar 13
0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
BIOLOGICALRotaTeq
2 mL oral administration at 2, 3 and 4 months
BIOLOGICALNimenrix
0.5 mL intramuscular injection at 12 months
BIOLOGICALM-M-RVAXPRO
0.5 mL intramuscular or subcutaneous injection at 13 months of age
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Days to 76 Days
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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-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) |
| Proportion of subjects with an anti-MenC titre ≥1:8 dil | Month 3 (One month after dose 1 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 |
| 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-polyribosylribitol phosphate concentration ≥1 µg/mL | Month 12 (Pre-booster) and Month 13 (One month post-booster) |
| 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 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) |
| Proportion of subjects with pertussis booster response | Month 13 (One month post-booster) |
| 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 ≥0.01 IU/mL | Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) |
Countries
Finland
Outcome results
None listed