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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005547-24 | EudraCT Number |
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Primary Series Primary objectives
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.
Primary Series Secondary objectives
Booster Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexavalent vaccine | Biological | 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) |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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-diphtheria concentration ≥0.01 IU/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Pasteur MSD Investigational Site 003 | Espoo | Finland | ||||
| Sanofi Pasteur MSD Investigational Site 001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30471953 | Derived | Vesikari T, Borrow R, Da Costa X, Thomas S, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers. Vaccine. 2018 Dec 18;36(52):8019-8027. doi: 10.1016/j.vaccine.2018.10.100. Epub 2018 Nov 22. | |
| 27939054 |
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|
| NeisVac-C | Biological | 0.5 mL intramuscular injection at 2 and 4 months of age |
|
|
| Prevenar 13 | Biological | 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) |
|
|
| RotaTeq | Biological | 2 mL oral administration at 2, 3 and 4 months |
|
|
| Nimenrix | Biological | 0.5 mL intramuscular injection at 12 months |
|
|
| M-M-RVAXPRO | Biological | 0.5 mL intramuscular or subcutaneous injection at 13 months of age |
|
|
| 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-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 |
| 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-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) |
| Helsinki |
| Finland |
| Sanofi Pasteur MSD Investigational Site 002 | Helsinki | Finland |
| Sanofi Pasteur MSD Investigational Site 011 | Jarvenpaa | Finland |
| Sanofi Pasteur MSD Investigational Site 010 | Kokkola | Finland |
| Sanofi Pasteur MSD Investigational Site 004 | Oulu | Finland |
| Sanofi Pasteur MSD Investigational Site 005 | Pori | Finland |
| Sanofi Pasteur MSD Investigational Site 009 | Seinäjoki | Finland |
| Sanofi Pasteur MSD Investigational Site 006 | Tampere | Finland |
| Sanofi Pasteur MSD Investigational Site 007 | Turku | Finland |
| Sanofi Pasteur MSD Investigational Site 008 | Vantaa | Finland |
| Vesikari T, Borrow R, Da Costa X, Richard P, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants. Vaccine. 2017 Jan 11;35(3):452-458. doi: 10.1016/j.vaccine.2016.11.053. Epub 2016 Dec 9. |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D013745 | Tetanus Toxoid |
| D017325 | Hepatitis B Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| D022242 | Pneumococcal Vaccines |
| C492535 | RotaTeq |
| D014612 | Vaccines |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014121 | Toxoids |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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