Clinical Trial: Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussi

Brief Summary: The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

Detailed Summary:

A multinational, multicenter, randomized, comparative, open-label, phase 3 study

Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products

Sponsor: Boryung Pharmaceutical Co., Ltd

Current Primary Outcome: Vaccine response rate [ Time Frame: 4 weeks after the three-dose primary vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Geometric mean titer (GMT) [ Time Frame: 4 weeks after the three-dose primary vaccination ]

Original Secondary Outcome: Same as current

Information By: Boryung Pharmaceutical Co., Ltd

Dates:
Date Received: April 27, 2015
Date Started: February 2015
Date Completion: April 2018
Last Updated: February 3, 2017
Last Verified: February 2017