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

• Sponsor: PT Bio Farma (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05482282
• Collaborator: Hasan Sadikin General Hospital (Other)
• Enrollment: 220
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site: 73.3
• Patients Per Site Per Month: 18.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diphtheria Vaccine Adverse Reaction; Tetanus Vaccine Adverse Reaction; Pertussis Vaccine Adverse Reaction; Haemophilus Influenzae Type B Vaccine Adverse Reaction; Hepatitis B Vaccine Adverse Reaction	Biological: Recombinant Hepatitis B new Bulk vaccine; Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine; Biological: Recombinant Hepatitis B vaccine (Registered BioFarma); Biological: Pentabio	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention studySubjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study
• Masking: Double (Participant, Investigator)
• Masking Description: Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To asses the local and systemic reactions within 30 minutes [30 minutes]

   Local reaction and systemic events occurring within 30 minutes after immunization.

2. To asses the local and systemic reactions within 30 minutes to 7 days after immunization [7 days]

   Local reaction and systemic events occurring after 30 minutes to 7 days after immunization.

3. To asses the local and systemic reactions within 7 days to 28 days after immunization [28 days]

   Local reaction and systemic events occurring after 7 days to 28 days following the vaccination.

4. To asses the serious adverse event [28 days]

   Any serious adverse event occuring from inclusion until 28 days after the last dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Garuda Primary Health Centre	Bandung	West Java	Indonesia
2	Ibrahim Adjie Primary Health Centre	Bandung	West Java	Indonesia
3	Puter Primary Health Centre	Bandung	West Java	Indonesia

Sponsors and Collaborators

• PT Bio Farma
• Hasan Sadikin General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PT Bio Farma
• ClinicalTrials.gov Identifier: NCT05482282
• Other Study ID Numbers: Penta BS22
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PT Bio Farma: DTP-HB-Hib Vaccine; Hepatitis B Vaccine
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Diphtheria; Hepatitis; Vaccines

Study Results

No Results Posted as of Aug 1, 2022