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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

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Eutravac

Intervention Type BIOLOGICAL

Other Intervention Names

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LG DTaP Vaccine Inj. (DTaP) Euvax B (Hepatitis B) Hepavax (Hepatitis B)

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes