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1. Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis

Author

Pedro Luiz Spinelli Coelho, Gustavo Lacerda da Silva Calestini, Fernando Salgueiro Alvo, Jefferson Michel de Moura Freitas, Paula Marcela Vilela Castro, and Tulio Konstantyner

Subjects
Vacinas contra papillomavirus, Efeitos adversos, Adolescente, Metanálise, Segurança, Pediatrics, RJ1-570
Abstract

Objective: To identify and quantify the adverse effects associated with the recombinant human papillomavirus (types 6, 11, 16 and 18) vaccine in adolescents. Data source: Systematic review of randomized clinical trials from PubMed, SciELO and Lilacs databases. Articles investigating the safety of the vaccine in subjects under 18 years and comparing the recombinant human papillomavirus types 6, 11, 16 and 18 vaccine with a control group were included. Meta-analyses were performed for the outcomes of pain, erythema, swelling and fever, using clinical trials with maximum Jadad score. Data synthesis: Fourteen studies were included. The most common adverse effects related to the human papillomavirus vaccine were effects with no severity (pain, erythema, edema, and fever). Five studies were used for the meta-analyses: pain-risk difference (RD)=11% (p

Published
2015
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2. Segurança da vacina papillomavirus humano 6, 11, 16 e 18 (recombinante): revisão sistemática e metanálise

Author

Tulio Konstantyner, Jefferson Michel de Moura Freitas, Fernando Salgueiro Alvo, Pedro Luiz Spinelli Coelho, Gustavo Lacerda da Silva Calestini, and Paula Marcela Vilela Castro

Subjects
Papillomavirus vaccines, medicine.medical_specialty, Vacinas contra papillomavirus, Adolescent, Erythema, Population, Segurança, Efeitos adversos, law.invention, Metanálise, Papillomavirus Vaccines, Randomized controlled trial, law, Internal medicine, medicine, Adverse effect, education, Adolescente, education.field_of_study, Adverse effects, business.industry, Jadad scale, Surgery, Clinical trial, Vaccination, Pediatrics, Perinatology and Child Health, Meta‐analysis, Safety, medicine.symptom, business
Abstract

ResumoObjetivoIdentificar e quantificar os efeitos adversos associados à vacina papillomavirus humano 6, 11, 16 e 18 (recombinante) em adolescentes.Fontes de dadosRevisão sistemática de ensaios clínicos randomizados nas bases de dados do PubMed, SciELO e Lilacs. Foram incluídos artigos que abordavam a segurança da vacina em menores de 18 anos e que comparavam a vacina papillomavirus humano 6, 11, 16 e 18 (recombinante) com grupo controle. Foram feitas metanálises para os desfechos de dor, eritema, edema e febre com o uso de ensaios clínicos com escore de Jadad máximo.Síntese dos dadosForam incluídos 14 estudos. Os efeitos adversos mais comuns relacionados à vacina foram intercorrências sem gravidade (dor, eritema, edema e febre). Cinco estudos foram usados para as metanálises, incluindo os desfechos: Dor – Diferença de Risco (DR)=11% (p

Published
2015
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