Paolo Durando1, Susanna Esposito2, Gianni Bona3, Mario Cuccia4, Maria Giuseppina Desole5, Giuseppe Ferrera6, Giovanni Gabutti7, Angelo Pellegrino8, Filippo Salvini9, Ouzama Henry10, Michael Povey11, Federico Marchetti12. 1. Department of Health Sciences, School of Medical and Pharmaceutical Sciences, University of Genoa and IRCCS AOU San Martino - IST, L.go R. Benzi, 10 (Building 3), Genoa 16132, Italy. Electronic address: durando@unige.it. 2. Pediatric Highly Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan 20122, Italy. Electronic address: susanna.esposito@unimi.it. 3. Corso Mazzini, 18, Clinica di Pediatria, Azienda Ospedaliera Maggiore della Carità, Piemonte, Novara 28100, Italy. Electronic address: gianni.bona@maggioreosp.novara.it. 4. Settore Igiene Pubblica, Corso Italia, 234, Servizio di Epidemiologia e Prevenzione, ASP di Catania, Sicilia, Catania 95129, Italy. Electronic address: mario.cuccia@aspct.it. 5. Via Rizzeddu, 21, Servizio di Igiene Pubblica, Azienda Unità Sanitaria Locale n. 1 di Sassari, Sardegna, Sassari 07100, Italy. Electronic address: madesole@aslsassari.it. 6. Centro Servizi, Via Aldo Licitra, 11, Dipartimento di Prevenzione e Igiene Pubblica, ASP di Ragusa, Sicilia, Ragusa, RG 97100, Italy. Electronic address: servizio.epidemiologia@asp.rg.it. 7. Via Fossato di Mortara 64b, Dip. Scienze Mediche, Università degli Studi di Ferrara, Ferrara, Italy. Electronic address: giovanni.gabutti@unife.it. 8. Corso Francia, 10, Servizio di Igiene e Sanità Pubblica, ASL CN1, Piemonte, Cuneo 12100, Italy. Electronic address: angelo.pellegrino@aslcn1.it. 9. Via Antonio di Rudinì, 8, Clinica Pediatrica Università di Milano, ASST Santi Paolo e Carlo, Lombardia, Milano 20142, Italy. Electronic address: filippo.salvini@asst-santipaolocarlo.it. 10. GSK Vaccines, Philadelphia, United States. Electronic address: ouzama.n.henry@gsk.com. 11. GSK Vaccines, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: michael.x.povey@gsk.com. 12. GSK Vaccines, Via A. Fleming 2, 37135 Verona, Italy. Electronic address: federico.e.marchetti@gsk.com.
Abstract
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 13-15months 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 42days later by MenC (MMRV group); or MenC followed 42days later by MMRV (MenC group). Blood samples were collected before and 43days 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 42days 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 42days 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.
RCT Entities:
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 13-15months 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 42days later by MenC (MMRV group); or MenC followed 42days later by MMRV (MenC group). Blood samples were collected before and 43days 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 42days 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 42days 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.
Authors: Eliane Matos Dos Santos; Tatiana Guimarães Noronha; Isabelle Soares Alves; Robson Leite de Souza Cruz; Clara Lucy de Vasconcellos Ferroco; Ricardo Cristiano Brum; Patricia Mouta Nunes de Oliveira; Marilda Mendonça Siqueira; Mariza Cristina Lima; Francisco Luzio de Paula Ramos; Camila de Marco Bragagnolo; Luiz Antonio Bastos Camacho; Maria de Lourdes de Sousa Maia Journal: Mem Inst Oswaldo Cruz Date: 2019-03-07 Impact factor: 2.743
Authors: Petra Zimmermann; Nicole Ritz; Kirsten P Perrett; Nicole L Messina; Fiona R M van der Klis; Nigel Curtis Journal: Front Immunol Date: 2021-04-02 Impact factor: 7.561