Back to resultsA Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
Primary Purpose
Healthy Infants
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eutravac
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Infants focused on measuring Healthy infants with over than 37 weeks gestation periods., over than 2.5Kg at at birth weight.
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea ST. Vincent's Hospital
- Daejeon St. Mary's Hospital
- Inha University Hospital
- Jeju National University Hospital
- Kyung Hee University Hospital
- Cha Hospital
- Korea Cancer Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Experimental group with 0-2-4-6 schedule
Active comparator group with 0-2-4-6 schedule
Experimental group with 2-4-6 schedule
Active comparator group with 2-4-6 schedule
Arm Description
HB at 0, Eutravac at 2-4-6
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Eutravac at 2-4-6
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Outcomes
Primary Outcome Measures
Seroprotection rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01896739
Brief Title
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
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Infants
Keywords
Healthy infants with over than 37 weeks gestation periods., over than 2.5Kg at at birth weight.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group with 0-2-4-6 schedule
Arm Type
Experimental
Arm Description
HB at 0, Eutravac at 2-4-6
Arm Title
Active comparator group with 0-2-4-6 schedule
Arm Type
Active Comparator
Arm Description
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Arm Title
Experimental group with 2-4-6 schedule
Arm Type
Experimental
Arm Description
Eutravac at 2-4-6
Arm Title
Active comparator group with 2-4-6 schedule
Arm Type
Active Comparator
Arm Description
Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB)
Intervention Type
Biological
Intervention Name(s)
Eutravac
Other Intervention Name(s)
LG DTaP Vaccine Inj. (DTaP), Euvax B (Hepatitis B), Hepavax (Hepatitis B)
Primary Outcome Measure Information:
Title
Seroprotection rate
Time Frame
After final immunisation at 4-8 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Catholic University of Korea ST. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Daejeon St. Mary's Hospital
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
ZIP/Postal Code
690-767
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Cha Hospital
City
Seoul
ZIP/Postal Code
135-913
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
ZIP/Postal Code
139-709
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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