Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

January 13, 2022 updated by: PT Bio Farma

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

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants

Study Type

Interventional

Enrollment (Actual)

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 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 Care

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 second to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Child concomitantly enrolled or scheduled to be enrolled in another trial.
  • Mother with HBsAg positive.
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
  • Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
  • Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
  • Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
  • Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
  • Received other vaccination with the exception of BCG and poliomyelitis.
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.

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: HepB + Penta batch 1
Recombinant Hepatitis B + DTP-HB-Hib batch 1
Biological: Recombinant Hepatitis B + DTP-HB-Hib
1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
Other Names:
  • Hep B + DTP-HB-Hib
Active Comparator: Hep B + Pentabio (registered)
Recombinant Hepatitis B + Pentabio (registered)
Biological: Hep B + Pentabio (registered)
1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
Other Names:
  • Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria
Time Frame: 28 days after immunization
Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer > 0.01 IU/ml, > 0.1 IU/ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive
28 days after immunization
Serological response to the pertussis component (agglutinins)
Time Frame: 28 days after immunization
Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer > 40, > 80, > 160 and > 320 (1/dil.), percentage of infants with increasing antibody titer > 4 times
28 days after immunization
Geometric mean of anti-HbsAg
Time Frame: 28 days after immunization
Geometric mean of anti-HbsAg, percentage of infants with titer > 10mIU/ml, percentage of infants with increasing antibody titer > 4 times and/ or percentage of infants with transition of seronegative to seropositive
28 days after immunization
Serological response to Hib/PRP
Time Frame: 28 days after immunization
Serological response to Hib/PRP: GMT, percentage of infants with titer >1 ug /ml ; > 0.15 ug /ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive
28 days after immunization
Seroconversion
Time Frame: 28 days after immunization
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer > 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control.
28 days after immunization

Collaborators and Investigators

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

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Eddy Fadliyana, 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 (Actual)

October 13, 2020

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Penta BS19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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