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

NCT03931239 | Completed

• 1 other identifier: VABIOTECH-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration

  Days 0 to 28 post-vaccination

Secondary Outcomes (1)

• Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration

  Baseline to 30 minutes post-vaccination

Study Arms (1)

Vaccination

EXPERIMENTAL

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

Interventions

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 BIOLOGICAL

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

Vaccination

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vabiotech: lead
• Vietstar Biomedical Research: collaborator

Study Sites (1)

Hung Yen, Kim Dong

Hưng Yên, Vietnam

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Haemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: March 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 3, 2019

Record last verified: 2019-04

Locations

VN (1)