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
Not Applicable
Completed
- Conditions
- DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type B
- Interventions
- 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
- Registration Number
- NCT03931239
- Lead Sponsor
- Vabiotech
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccination 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 DTPw-HB-Hib vaccine
- Primary Outcome Measures
Name Time Method Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration Days 0 to 28 post-vaccination
- Secondary Outcome Measures
Name Time Method Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration Baseline to 30 minutes post-vaccination
Trial Locations
- Locations (1)
Hung Yen, Kim Dong
🇻🇳Hung Yen, Vietnam