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

NCT01896739 | Completed Phase 3

• 1 other identifier: LG-VACL004
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Healthy infants with over than 37 weeks gestation periods.; over than 2.5Kg at at birth weight.

Outcome Measures

Primary Outcomes (1)

• Seroprotection rate

  After final immunisation at 4-8 weeks

Study Arms (4)

Experimental group with 0-2-4-6 schedule

EXPERIMENTAL

HB at 0, Eutravac at 2-4-6

Biological: Eutravac

Active comparator group with 0-2-4-6 schedule

ACTIVE COMPARATOR

Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)

Biological: Eutravac

Experimental group with 2-4-6 schedule

EXPERIMENTAL

Eutravac at 2-4-6

Biological: Eutravac

Active comparator group with 2-4-6 schedule

ACTIVE COMPARATOR

Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)

Biological: Eutravac

Interventions

Eutravac BIOLOGICAL

Also known as: LG DTaP Vaccine Inj. (DTaP), Euvax B (Hepatitis B), Hepavax (Hepatitis B)

Active comparator group with 0-2-4-6 schedule; Active comparator group with 2-4-6 schedule; Experimental group with 0-2-4-6 schedule; Experimental group with 2-4-6 schedule

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
• Signed parental or legally acceptable representative's informed consent was obtained

You may not qualify if:

• Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
• History of diphtheria, tetanus, pertussis or hepatitis B disease
• History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (7)

Daejeon St. Mary's Hospital

Daejeon, Daejeon, 301-723, South Korea

Location

The Catholic University of Korea ST. Vincent's Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

Location

Inha University Hospital

Incheon, Incheon, 400-711, South Korea

Location

Jeju National University Hospital

Jeju City, Jeju-do, 690-767, South Korea

Location

Kyung Hee University Hospital

Seoul, Seoul, 130-872, South Korea

Location

Cha Hospital

Seoul, Seoul, 135-913, South Korea

Location

Korea Cancer Center Hospital

Seoul, Seoul, 139-709, South Korea

Location

MeSH Terms

Interventions

Euvax-B; Hepatitis B Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: August 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

KR (7)