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

Healthy Infants Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896739
• Other study ID #: LG-VACL004
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2013
• Last updated: July 8, 2013
• Start date: August 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Infants
• Hepatitis B

Intervention

Biological:
• Eutravac

Locations

Country	Name	City	State
Korea, Republic of	Daejeon St. Mary's Hospital	Daejeon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Cha Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea ST. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate		After final immunisation at 4-8 weeks	No