Status:
COMPLETED
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
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy Infants
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01896739
Start Date
August 1 2009
End Date
November 1 2011
Last Update
July 11 2013
Active Locations (7)
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1
Daejeon St. Mary's Hospital
Daejeon, Daejeon, South Korea, 301-723
2
The Catholic University of Korea ST. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 442-723
3
Inha University Hospital
Incheon, Incheon, South Korea, 400-711
4
Jeju National University Hospital
Jeju City, Jeju-do, South Korea, 690-767