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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931239
• Other study ID #: VABIOTECH-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2019
• Source: Vabiotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type B
• Hepatitis
• Hepatitis B
• Influenza, Human
• Pertussis
• Tetanus
• Whooping Cough

Intervention

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
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

Locations

Country	Name	City	State
Vietnam	Hung Yen, Kim Dong	Hung Yen

Sponsors (2)

Lead Sponsor	Collaborator
Vabiotech	Vietstar Biomedical Research

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration		Days 0 to 28 post-vaccination
Secondary	Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration		Baseline to 30 minutes post-vaccination