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

July 8, 2013 updated by: LG Life Sciences

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 301-723
        • Daejeon St. Mary's hospital
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Jeju, Korea, Republic of, 690-767
        • Jeju National University Hospital
      • Seoul, Korea, Republic of, 130-872
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 135-913
        • Cha Hospital
      • Seoul, Korea, Republic of, 139-709
        • Korea Cancer Center Hospital
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • The Catholic University of Korea St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group with 0-2-4-6 schedule
HB at 0, Eutravac at 2-4-6
Biological: Eutravac
Other Names:
  • LG DTaP Vaccine Inj. (DTaP)
  • Euvax B (Hepatitis B)
  • Hepavax (Hepatitis B)
Active Comparator: Active comparator group with 0-2-4-6 schedule
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Biological: Eutravac
Other Names:
  • LG DTaP Vaccine Inj. (DTaP)
  • Euvax B (Hepatitis B)
  • Hepavax (Hepatitis B)
Experimental: Experimental group with 2-4-6 schedule
Eutravac at 2-4-6
Biological: Eutravac
Other Names:
  • LG DTaP Vaccine Inj. (DTaP)
  • Euvax B (Hepatitis B)
  • Hepavax (Hepatitis B)
Active Comparator: Active comparator group with 2-4-6 schedule
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Biological: Eutravac
Other Names:
  • LG DTaP Vaccine Inj. (DTaP)
  • Euvax B (Hepatitis B)
  • Hepavax (Hepatitis B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroprotection rate
Time Frame: After final immunisation at 4-8 weeks
After final immunisation at 4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VACL004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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