The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

Study Overview
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Brief Summary
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The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

Detailed Description
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This will be an open label, single group, bridging study. Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval. This study was performed in strict accordance with Good Clinical Practice.

Official Title
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An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses

Conditions
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Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B

Intervention / Treatment
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* Biological: Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and enrollment Subject born at full term of pregnancy (greater or equal to 37 weeks) and Birth weight ≥2500 grams Weight ≥ 3,300 grams at the time of screeningSubject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator Parent / legal representative can understand and be able to comply with the requirements of the protocol Subjects born to mothers who are seronegative to HIV, HBV and HCV through a blood test or maternity record. Parent / legal representative is willing to voluntarily sign the consent form for the participant Exclusion Criteria: History of diphtheria, tetanus, pertussis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically) Fever (temperature ≥37.50C) or hypothermia (≤35.50C) or acute illness / infection that requires treatment. Previous vaccination against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases. Known allergy to any component of the vaccine; Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. Being treated with anticoagulants or at high risk of bleeding. A family history of SIDS (sudden infant death syndrome) Have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive therapy, radiation therapy in the last 4 weeks. Have participated in another clinical trial within 30 days prior to the study vaccination or may participate in the course of the study. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects. History of any neurological disorders or seizures

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination<br>DTPw-HB-Hib vaccine | Biological: Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval<br>* An openlabel, multicentric, bridging study to assess the safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine (Adsorbed) manufactured by Serum Institute of India Pvt. Ltd in Vietnamese infants aged 6-12 weeks, given as a 3-dose regime, with 4 week intervals between the doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration |  | Days 0 to 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration |  | Baseline to 30 minutes post-vaccination |