Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

April 5, 2024 updated by: PT Bio Farma

Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group.

The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia
        • Garuda Primary Health Centre
      • Bandung, West Java, Indonesia
        • Ibrahim Adjie Primary Health Centre
      • Bandung, West Java, Indonesia
        • Puter Primary Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy, full term, newborns infants.
  2. Infant born after 37-42 weeks of pregnancy.
  3. Infant weighing 2500 gram or more at birth.
  4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
  5. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

Exclusion Criteria:

  1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
  2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
  3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
  4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
  5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
  6. Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
  7. Child received other vaccination with the exception of BCG and poliomyelitis.
  8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
  10. Mother suspected of immunodeficiency disease based on anamnesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk
1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
Biological: Recombinant Hepatitis B new Bulk vaccine

1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma)

1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region.

Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
Active Comparator: Hep B (Registered) + Pentabio (Registered)
1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
Biological: Recombinant Hepatitis B vaccine (Registered BioFarma)
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
Biological: Pentabio
3 doses of Pentabio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
Time Frame: 28 days
Percentage of infants with anti-diphtheria titer and anti-tetanus titer more than 0.01 IU/ml, anti HbsAg titer more than 10 mIU/ml, and anti PRP-TT titer more than 0.15 microgram/ml 28 days after the last injection of DTP-HB-Hib using new Hepatitis B bulk (Bio Farma) vaccine group.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the local and systemic reactions within 30 minutes
Time Frame: 30 minutes
Local reaction and systemic events occurring within 30 minutes after immunization.
30 minutes
To asses the local and systemic reactions within 30 minutes to 7 days after immunization
Time Frame: 7 days
Local reaction and systemic events occurring after 30 minutes to 7 days after immunization.
7 days
To asses the local and systemic reactions within 7 days to 28 days after immunization
Time Frame: 28 days
Local reaction and systemic events occurring after 7 days to 28 days following the vaccination.
28 days
To asses the serious adverse event
Time Frame: 28 days
Any serious adverse event occuring from inclusion until 28 days after the last dose
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Collaborators

Hasan Sadikin General Hospital

Investigators

  • Principal Investigator: Eddy Fadlyana, MD, Hasan Sadikin General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Penta BS22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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