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

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Healthy Infants

Treatments: Biological: Eutravac

Study type: Interventional

Funder types: Industry

Identifiers

NCT01896739

LG-VACL004

Details and patient eligibility

About

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.

Enrollment: 289 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 4 patient groups

Experimental group with 0-2-4-6 schedule

Experimental group

Description:

HB at 0, Eutravac at 2-4-6

Treatment:

Biological: Eutravac

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

Active Comparator group

Description:

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

Treatment:

Biological: Eutravac

Experimental group with 2-4-6 schedule

Experimental group

Description:

Eutravac at 2-4-6

Treatment:

Biological: Eutravac

Active comparator group with 2-4-6 schedule

Active Comparator group

Description:

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

Treatment:

Biological: Eutravac