NCT01896739

A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants

A Multicentre, Comparative, Open-label, Randomized, Phase III Study to Assess the Immunogenicity and Safety of EutravacTMinj (DTaP-HB Combined Vaccine) Administered at 2,4, 6 Months of Age Compared With DTaP Vaccine at 2, 4, 6 Months of Age Combined Administered Monovalent Hepatitis B Vaccine Administered at Birth, 1, 6 Months of Age in Healthy Infants.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis \[DTaP\] Hepatitis B \[HB\] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
BIOLOGICAL	Eutravac

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2013-07-11
• Last updated: 2013-07-11

Locations

7 sites across 1 country: South Korea