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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Neisseria Meningitidis, Bacterial Infections, Virus Diseases
Interventions: Hexavalent vaccine, NeisVac-C, Prevenar 13, RotaTeq, Nimenrix
Countries: Finland
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.
Sex: ALL
Age: 46 Days to 76 Days
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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.
- Espoo, Finland
- Helsinki, Finland
- Helsinki, Finland
- Jarvenpaa, Finland
- Kokkola, Finland
- Oulu, Finland
- Pori, Finland
- Seinäjoki, Finland
- Tampere, Finland
- Turku, Finland
- Vantaa, Finland