The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy
| Autor: | Giuseppe Ferrera, Paolo Durando, Giovanni Gabutti, Angelo Pellegrino, Michael Povey, Filippo Salvini, Susanna Esposito, Ouzama Henry, Gianni Bona, Mario Cuccia, Federico Marchetti, Maria Giuseppina Desole |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Herpesvirus 3 Human Pediatrics Immunology and Microbiology (all) Vaccination schedule Antibodies Viral Measles-mumps-rubella-varicella vaccine Immunogenicity Vaccine 0302 clinical medicine Conjugated meningococcal C vaccine Immunogenicity Italy Safety Medicine (all) Molecular Medicine Veterinary (all) Public Health Environmental and Occupational Health Infectious Diseases 030212 general & internal medicine Antibody titer Healthy Volunteers Vaccination Mumps virus Seroconversion Female Public Health medicine.medical_specialty Fever Socio-culturale Enzyme-Linked Immunosorbent Assay Meningococcal Vaccines Rubella Measles Chickenpox Vaccine 03 medical and health sciences Immunology and Microbiology(all) 030225 pediatrics medicine Humans Vaccines Combined Immunization Schedule General Veterinary General Immunology and Microbiology business.industry Environmental and Occupational Health Infant medicine.disease veterinary(all) Confidence interval Meningococcal Infections Measles virus business Rubella virus Measles-Mumps-Rubella Vaccine |
| Popis: | Introduction Multiple vaccination visits and administrations can be stressful for infants, parents and healthcare providers. Multivalent combination vaccines can deliver the required number of antigens in fewer injections and clinic visits, while vaccine co-administration can also reduce the number of visits. This non-inferiority study was undertaken to evaluate the feasibility of co-administering a combined measles-mumps-rubella-varicella (MMRV) vaccine with conjugated meningococcal C (MenC) vaccine in a large cohort of healthy Italian toddlers. Methods Healthy subjects aged 13–15 months were randomized (2:1:1) to receive single doses of either: co-administered MMRV + MenC at the same visit (MMRV + MenC group); or MMRV followed 42 days later by MenC (MMRV group); or MenC followed 42 days later by MMRV (MenC group). Blood samples were collected before and 43 days after vaccination. Antibody titers against MMRV were measured using ELISA. Functional-anti-meningococcal-serogroup activity (rSBAMenC) was assessed using a serum bactericidal test. Solicited local and general reactions were recorded for up to 4 and 42 days post-vaccination, respectively. Non-inferiority of MMRV + MenC to MMRV (post-dose-1 seroconversion rates) and MMRV + MenC to MenC (post-dose-1 seroprotection rates) was achieved if the lower limit (LL) of the 95% confidence interval (CI) for the group difference was ⩾−10% for each antigen. Results 716 subjects were enrolled in the study. At 42 days post-vaccination, the MMRV seroconversion rates were 99.3% (measles), 94.5% (mumps), 100% (rubella) and 99.7% (varicella) in the MMRV + MenC group, and 99.4%, 93.2%, 100% and 100%, respectively, in the MMRV group. The seroprotection rates against rSBA-MenC were 98.3% in the MMRV + MenC group and 99.3% in the MenC group. Non-inferiority was reached for all the vaccine antigens. The safety profiles were as expected for these vaccines. Conclusion The immune responses elicited by co-administered MMRV + MenC were non-inferior to those elicited by MMRV or MenC alone and support vaccination of children with both vaccines at a single visit. Clinical Trials registration: NCT01506193 . |
| Databáze: | OpenAIRE |
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