search
Back to results

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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
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
Sponsored by
Vabiotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts 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

Sites / Locations

  • Hung Yen, Kim Dong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccination

Arm Description

DTPw-HB-Hib vaccine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2019
Last Updated
May 1, 2019
Sponsor
Vabiotech
Collaborators
Vietstar Biomedical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT03931239
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vabiotech
Collaborators
Vietstar Biomedical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccination
Arm Type
Experimental
Arm Description
DTPw-HB-Hib vaccine
Intervention Type
Biological
Intervention Name(s)
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
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
Time Frame
Days 0 to 28 post-vaccination
Secondary Outcome Measure Information:
Title
Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
Time Frame
Baseline to 30 minutes post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hung Yen, Kim Dong
City
Hung Yen
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs