| Author | Martins, Reinaldo de Menezes | |
| Author | Curran, Birute | |
| Author | Maia, Maria de Lourdes Souza | |
| Author | Ribeiro, Maria das Graças Tavares | |
| Author | Camacho, Luiz Antonio Bastos | |
| Author | Freire, Marcos da Silva | |
| Author | Yamamura, Anna Maya Yoshida | |
| Author | Siqueira, Marilda Agudo Mendonça Teixeira de | |
| Author | Lemos, Maria Cristina F | |
| Author | Albuquerquer, Elizabeth Maciel de | |
| Author | von Doellinger, Vanessa dos Reis | |
| Author | Homma, Akira | |
| Author | Saganic, Laura | |
| Author | Jarrahian, Courtney | |
| Author | Royals, Michael | |
| Author | Zehrung, Darin | |
| Access date | 2015-06-17T12:05:24Z | |
| Available date | 2015-06-17T12:05:24Z | |
| Document date | 2015 | |
| Citation | MARTINS, Reinaldo de Menezes et al. Immunogenicity and safety of measles–mumps–rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: A randomized non-inferiority study. Contemporary Clinical Trials, v. 41, p. 1–8, Mar. 2015. | pt_BR |
| ISSN | 1551-7144 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/10880 | |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | restricted access | |
| Title | Immunogenicity and safety of measles–mumps–rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: A randomized non-inferiority study | pt_BR |
| Type | Article | |
| DOI | 10.1016/j.cct.2014.11.014 | pt_BR |
| Abstract | This study aimed to determine if immunogenicity to measles–mumps–rubella vaccine
delivered to infants via a disposable-syringe jet injector (DSJI) was non-inferior to that
administered by needle and syringe (NS). Vaccination safety was evaluated, as were the
use, performance, and acceptability of each delivery method. The DSJI was the PharmaJet®
2009 generation-1 device (G1) and the vaccine was measles–mumps–rubella vaccine from
Bio-Manguinhos. Five hundred eighty-two healthy Brazilian infants were randomized to
receive vaccine via G1 or NS. Seroconversion rates against measles and mumps viruses in
the G1 treatment group did not meet non-inferiority criteria when compared with the NS
group; however, responses in the G1 group to rubella virus were non-inferior to those of NS
vaccinees. Most adverse events were mild or moderate. Crying after injection was more
frequent in the NS group, and local skin reactions were more common in the G1 group. Five
serious adverse events were judged causally unrelated to treatment and all resolved.
Parents/guardians expressed a strong preference for G1 over NS for their children.
Vaccinators found the G1 easy to use but noted incomplete vaccine delivery in some
cases. Although the G1 has been superseded by an updated device, our results are important
for the continued improvement and evaluation of DSJIs, which have the potential to
overcome many of the challenges and risks associated with needle-based injections. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | PATH. Seattle, WA, USA. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sérgio Arouca. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Secretaria Municipal de Saúde do Rio de Janeiro. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | PATH. Seattle, WA, USA. | pt_BR |
| Affilliation | PATH. Seattle, WA, USA. | pt_BR |
| Affilliation | PharmaJet. CO, USA. | pt_BR |
| Affilliation | PATH. Seattle, WA, USA. | pt_BR |
| Subject | Disposable-syringe jet injector (DSJI) | pt_BR |
| Subject | Needle-free | pt_BR |
| Subject | Vaccination | pt_BR |
| Subject | Measles–mumps–rubella vaccine | pt_BR |
| Subject | Immunogenicity | pt_BR |
| Subject | Acceptability | pt_BR |
| Subject | Brazil | pt_BR |
| DeCS | Vacina contra Sarampo-Caxumba-Rubéola | pt_BR |
| DeCS | Vacinação | pt_BR |
| DeCS | Aceitação pelo Paciente de Cuidados de Saúde | pt_BR |
| DeCS | Crianças | pt_BR |
| Embargo date | Mar. 2016 | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
