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CompletedNCT04071379Updated Jan 18, 2022

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

A Phase 3 interventional study of Recombinant Hepatitis B + DTP-HB-Hib and Hep B + Pentabio (registered) in Immunogenicity and Safety, sponsored by PT Bio Farma. Completed at 3 sites in Indonesia. Open to participants aged 0 Days to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.

Sponsored by PT Bio Farma · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
0 Days to 3 Days
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Immunogenicity
  • Safety
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 220 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

PT Bio Farma is the lead sponsor of 44 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 3 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    HepB + Penta batch 1

    Recombinant Hepatitis B + DTP-HB-Hib batch 1

    Biological: Recombinant Hepatitis B + DTP-HB-Hib

  • Active comparator
    Hep B + Pentabio (registered)

    Recombinant Hepatitis B + Pentabio (registered)

    Biological: Hep B + Pentabio (registered)

Interventions

  • BiologicalRecombinant Hepatitis B + DTP-HB-Hib

    1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib

    Also known as: Hep B + DTP-HB-Hib

  • BiologicalHep B + Pentabio (registered)

    1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

    Also known as: Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)

06

What researchers measure

Primary outcomes

  1. To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk

    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.

    Time frame: 28 days after immunization

Secondary outcomes

  1. Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria

    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

    Time frame: 28 days after immunization

  2. Serological response to the pertussis component (agglutinins)

    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

    Time frame: 28 days after immunization

  3. Geometric mean of anti-HbsAg

    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

    Time frame: 28 days after immunization

  4. Serological response to Hib/PRP

    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

    Time frame: 28 days after immunization

  5. Seroconversion

    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.

    Time frame: 28 days after immunization

07

Study locations

3 sites
  • Garuda Primary Health Centre
    Bandung, West Java, Indonesia
  • Ibrahim Adjie Primary Health Centre
    Bandung, West Java, Indonesia
  • Puter Primary Health Care
    Bandung, West Java, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04071379
Lead sponsor
PT Bio Farma
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
Oct 13, 2020
Primary completion
Apr 6, 2021
Completion
Dec 16, 2021
Last update
Jan 18, 2022

Study contacts

Eddy Fadliyana
principal investigator · Hasan Sadikin General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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