健康な日本人乳幼児を対象とした、7価肺炎球菌結合型ワクチンとジフテリア・破傷風・無細胞百日咳混合ワクチン（DTaP）の併用投与に関する臨床試験。

基本情報

NCT ID

NCT01250756

ステータス

完了

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

321

治験依頼者名

Pfizer

概要

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

対象疾患

介入

依頼者（Sponsor）

実施施設 (18)