Diphtheria, Haemophilus Influenzae Type B, Hepatitis B, Pertussis, Tetanus
Conditions
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.
Interventions
BIOLOGICALStudy 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
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
Sponsors
Vietstar Biomedical Research
Vabiotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration | Days 0 to 28 post-vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration | Baseline to 30 minutes post-vaccination |
Countries
Vietnam
Outcome results
None listed