NCT02458183

Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 7 Weeks – 10 Weeks
• Healthy volunteers: Accepted

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 description

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

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV combination vaccine	0.5-mL IM
BIOLOGICAL	DTaP vaccine and IPV vaccine	0.5-mL IM

Timeline

• Start date: 2015-02-02
• Primary completion: 2017-12-19
• Completion: 2018-05-05
• First posted: 2015-06-01
• Last updated: 2023-06-28

Locations

20 sites across 2 countries: South Korea, Thailand