Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China.
BMJ Open
; 6(10): e012488, 2016 10 19.
Article
em En
| MEDLINE
| ID: mdl-27798013
ABSTRACT
INTRODUCTION:
The invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae pose an enormous threat to children under 5â years of age. However, routine use of pneumococcal conjugate vaccines could aid in reducing the incidence of IPDs. The purpose of this clinical trial is to assess the non-inferiority of the investigational 13-valent pneumococcal conjugate vaccine (PCV13) to the currently licensed 7-valent pneumococcal conjugate vaccine (PCV7). METHODS ANDANALYSIS:
1040 infants will receive a three-dose series of either PCV13 or PCV7 at ages 3, 4 and 5â months, respectively, and a booster dose at 12-15â months. Primary end points are the percentage of participants reaching a serotype-specific IgG concentration of ≥0.35â µg/mL and the IgG antibody geometric mean concentrations (GMCs) measured 30â days after the primary immunisation. Secondary end points include the percentage of vaccine recipients reaching a serotype-specific IgG concentration threshold of 1.0â µg/mL, the percentage of participants reaching the pneumococcal opsonophagocytic assay (OPA) titre threshold of 18, and the geometric mean titres (GMTs) of OPA measured 30â days after primary and booster doses. The number of standard IgG responders and IgG GMCs measured 30â days after the booster immunisation will also be determined. To evaluate differences between two groups, the sequential testing of the non-inferiority of PCV13 for the seven common serotypes and its effectiveness in treating the six additional serotypes will be performed. ETHICS AND DISSEMINATION Ethics approvals have been granted by the Ethics Committees at the three provinces involved in this study Shanxi, Henan and Hebei. The trial will be reported in accordance with the CONSORT guidance. TRIAL REGISTRATION NUMBER NCT02736240.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Infecções Pneumocócicas
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Streptococcus pneumoniae
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Vacinas Pneumocócicas
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Vacina Pneumocócica Conjugada Heptavalente
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Imunogenicidade da Vacina
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Female
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Humans
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Infant
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Male
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article