Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
1 other identifier
interventional
465
1 country
3
Brief Summary
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
November 15, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedNovember 15, 2024
October 1, 2024
8 months
November 13, 2024
November 13, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
From enrollment to 7 days after first dose
Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
From enrollment up to 28 days after third dose
Secondary Outcomes (18)
Phase I: Safety of the vaccine within 28 days after last dose
From enrollment to 28 days after each dose
Phase I: Safety of the vaccine within 6 months after last dose
From enrollment up to 6 months after the last dose
Phase I: Comparison of safety within 28 days after each dose between vaccines and active control
From enrollment to 28 days after each dose
Phase I: Comparison of safety until 6 months after last dose between vaccines and active control
From enrollment to 6 months after last dose
Phase I: Routine laboratory evaluation that probably related to the vaccination
From enrollment to 7 days after first dose
- +13 more secondary outcomes
Study Arms (3)
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
EXPERIMENTAL0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
EXPERIMENTAL0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses.
Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®
ACTIVE COMPARATOR0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses.
Interventions
0,5 ml DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses. Vaccine is injected intramuscularly in left anterolateral thigh.
0,5 ml injected of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B three-dose regimen with 28 days interval between doses. Injected intramuscularly in left anterolateral thigh.
The control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml IPV (Sinovac)® injected in three-dose regimen with 28 days interval between doses. Registered DTwP-Hepatitis B-Hib Vaccine are injected intramuscularly into the left antero-lateral thigh region. IPV (Sinovac)® vaccine are injected intramuscularly into the right mid-lateral thigh region
Eligibility Criteria
You may qualify if:
- Infant 6-11 weeks of age.
- Infant born after 37-42 weeks of pregnancy.
- Infant weighing more than 2.5 kg at birth.
- Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.
You may not qualify if:
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
- Known history of allergy to any component of the vaccines.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Known history of congenital or acquired immunodeficiency (including HIV infection).
- Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
- Faculty of Medicine Universitas Padjadjarancollaborator
Study Sites (3)
Garuda Primary Health Centre
Bandung, West Java, Indonesia
Ibrahim Adjie Priamry Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Centre
Bandung, West Java, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2024
First Posted
November 15, 2024
Study Start
March 1, 2025
Primary Completion
October 31, 2025
Study Completion (Estimated)
September 30, 2026
Last Updated
November 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share