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 Overview
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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.

Official Title
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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.

Conditions
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Healthy Infants

Intervention / Treatment
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* Biological: Eutravac


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group with 0-2-4-6 schedule<br>HB at 0, Eutravac at 2-4-6 | Biological: Eutravac<br> <br> * Other names: Hepavax (Hepatitis B);|
| Active Comparator: Active comparator group with 0-2-4-6 schedule<br>Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) | Biological: Eutravac<br> <br> * Other names: Hepavax (Hepatitis B);|
| Experimental: Experimental group with 2-4-6 schedule<br>Eutravac at 2-4-6 | Biological: Eutravac<br> <br> * Other names: Hepavax (Hepatitis B);|
| Active Comparator: Active comparator group with 2-4-6 schedule<br>Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) | Biological: Eutravac<br> <br> * Other names: Hepavax (Hepatitis B);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate |  | After final immunisation at 4-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy infants with over than 37 weeks gestation periods., over than 2.5Kg at at birth weight.