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

Primary Purpose

Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction

Status
Not yet recruiting
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Recombinant Hepatitis B new Bulk vaccine
DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
Recombinant Hepatitis B vaccine (Registered BioFarma)
Pentabio
Sponsored by
PT Bio Farma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria Vaccine Adverse Reaction focused on measuring DTP-HB-Hib Vaccine, Hepatitis B Vaccine

Eligibility Criteria

1 Day - 3 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Garuda Primary Health Centre
  • Ibrahim Adjie Primary Health Centre
  • Puter Primary Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk

Hep B (Registered) + Pentabio (Registered)

Arm Description

1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine

1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2022
Last Updated
July 29, 2022
Sponsor
PT Bio Farma
Collaborators
Hasan Sadikin General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05482282
Brief Title
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
Collaborators
Hasan Sadikin General Hospital

4. Oversight

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

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction, Hepatitis B Vaccine Adverse Reaction
Keywords
DTP-HB-Hib Vaccine, Hepatitis B Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk
Arm Type
Experimental
Arm Description
1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
Arm Title
Hep B (Registered) + Pentabio (Registered)
Arm Type
Active Comparator
Arm Description
1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
Intervention Type
Biological
Intervention Name(s)
Recombinant Hepatitis B new Bulk vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
Intervention Description
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
Intervention Type
Biological
Intervention Name(s)
Recombinant Hepatitis B vaccine (Registered BioFarma)
Intervention Description
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
Intervention Type
Biological
Intervention Name(s)
Pentabio
Intervention Description
3 doses of Pentabio
Primary Outcome Measure Information:
Title
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To asses the local and systemic reactions within 30 minutes
Description
Local reaction and systemic events occurring within 30 minutes after immunization.
Time Frame
30 minutes
Title
To asses the local and systemic reactions within 30 minutes to 7 days after immunization
Description
Local reaction and systemic events occurring after 30 minutes to 7 days after immunization.
Time Frame
7 days
Title
To asses the local and systemic reactions within 7 days to 28 days after immunization
Description
Local reaction and systemic events occurring after 7 days to 28 days following the vaccination.
Time Frame
28 days
Title
To asses the serious adverse event
Description
Any serious adverse event occuring from inclusion until 28 days after the last dose
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0). Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis 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)). Child received other vaccination with the exception of BCG and poliomyelitis. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth) Mother suspected of immunodeficiency disease based on anamnesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rini Mulia Sari, MD
Phone
+622033755
Ext
14102
Email
rini.mulia@biofarma.co.id
First Name & Middle Initial & Last Name or Official Title & Degree
Mita Puspita, MD
Phone
+622033755
Ext
5045
Email
mita.puspita@biofarma.co.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddy Fadlyana, MD
Organizational Affiliation
Hasan Sadikin General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Garuda Primary Health Centre
City
Bandung
State/Province
West Java
Country
Indonesia
Facility Name
Ibrahim Adjie Primary Health Centre
City
Bandung
State/Province
West Java
Country
Indonesia
Facility Name
Puter Primary Health Centre
City
Bandung
State/Province
West Java
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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