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

Vabiotech

Status

Completed

Conditions

Diphtheria

Haemophilus Influenzae Type B

Hepatitis B

Pertussis

Tetanus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03931239

VABIOTECH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

222 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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