NCT04071379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

August 26, 2019

Last Update Submit

January 13, 2022

Conditions

ImmunogenicitySafety

Outcome Measures

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.

    28 days after immunization

Secondary Outcomes (5)

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

    28 days after immunization

  • Serological response to the pertussis component (agglutinins)

    28 days after immunization

  • Geometric mean of anti-HbsAg

    28 days after immunization

  • Serological response to Hib/PRP

    28 days after immunization

  • Seroconversion

    28 days after immunization

Study Arms (2)

HepB + Penta batch 1

EXPERIMENTAL

Recombinant Hepatitis B + DTP-HB-Hib batch 1

Biological: Recombinant Hepatitis B + DTP-HB-Hib

Hep B + Pentabio (registered)

ACTIVE COMPARATOR

Recombinant Hepatitis B + Pentabio (registered)

Biological: Hep B + Pentabio (registered)

Interventions

Recombinant Hepatitis B + DTP-HB-HibBIOLOGICAL

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
HepB + Penta batch 1
Hep B + Pentabio (registered)BIOLOGICAL

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)
Hep B + Pentabio (registered)

Eligibility Criteria

Age0 Days - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Garuda Primary Health Centre

Bandung, West Java, Indonesia

Location

Ibrahim Adjie Primary Health Centre

Bandung, West Java, Indonesia

Location

Puter Primary Health Care

Bandung, West Java, Indonesia

Location

Study Officials

  • Eddy Fadliyana

    Hasan Sadikin General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

October 13, 2020

Primary Completion

April 6, 2021

Study Completion

December 16, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

ID(3)