> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-ii-open-label-randomized-safety-and-immunogenicity-bfb8e100-95ce-4a58-837c-1b489ed8dce4 > Record changed: 2026-10-13 # Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants NCT06690515 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Participants 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Lead sponsor PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Start date 2025-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Short title** Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Official title** Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Dates **Completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **First posted** 2024-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Registry last updated** 2024-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Primary completion date** 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Start date** 2025-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Size and sites **Participants** 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Planned participants** 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Lead sponsor** PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Identifiers **Registry ID** NCT06690515 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **ClinicalTrials.gov ID** NCT06690515 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Outcomes ### Primary outcomes 1. Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose Timeframe: From enrollment to 7 days after first dose Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose 2. Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Timeframe: From enrollment up to 28 days after third dose Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine ### Secondary outcomes 1. Phase I: Safety of the vaccine within 28 days after last dose Timeframe: From enrollment to 28 days after each dose Number and percentage of solicited and unsolicited adverse events within 28 days after each dose 2. Phase I: Safety of the vaccine within 6 months after last dose Timeframe: From enrollment up to 6 months after the last dose Number and percentage of subjects with serious adverse events until 6 months after last dose 3. Phase I: Comparison of safety within 28 days after each dose between vaccines and active control Timeframe: From enrollment to 28 days after each dose Comparison of number and percentage of subjects with adverse events between vaccine and control group within 28 days after each dose 4. Phase I: Comparison of safety until 6 months after last dose between vaccines and active control Timeframe: From enrollment to 6 months after last dose Comparison of number and percentage of subjects with serious adverse events between vaccine and control group until 6 months after last dose 5. Phase I: Routine laboratory evaluation that probably related to the vaccination Timeframe: From enrollment to 7 days after first dose Any deviation from routine laboratory evaluation that probably related to the dosing 7 days after first dose. 6. Phase I: Serological response to diphteria toxoid and tetanus toxoid Timeframe: 28 days after the last dose immunization 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. 7. Phase I: Serological response to the pertussis component (agglutinins) Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times 8. Phase I: Geometric mean of anti-HbsAg Timeframe: 28 days after the last dose immunization 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. 9. Phase I: Serological response to Hib/PRP Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive 10. Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity) Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive 11. Phase II: Serological response to diphtheria toxoid, tetanus toxoid Timeframe: 28 days after the last dose immunization 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 12. Phase II: Serological response to the pertussis component (agglutinins) Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times 13. Phase II: Geometric mean of anti-HbsAg Timeframe: 28 days after the last dose immunization 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. 14. Phase II: Serological response to Hib/PRP Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive 15. Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity) Timeframe: 28 days after the last dose immunization GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive 16. Phase II: Safety of vaccine within 30 minutes after immunization Timeframe: 30 minutes after immunization Local reaction and systemic events occurring within 30 minutes after immunization 17. Phase II: Safety of vaccine within 7 days after immunization Timeframe: Within 7 days after immunization Local reaction and systemic events occurring within 7 days after immunization 18. Phase II: Safety of vaccine after 7 days to 28 days following the vaccination Timeframe: From 7 days to 28 days following the vaccination Local reaction and systemic events occurring after the 7 days to 28 days following the vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 11 Weeks **Healthy volunteers** Yes ### Inclusion criteria 1. Infant 6-11 weeks of age. 2. Infant born after 37-42 weeks of pregnancy. 3. Infant weighing more than 2.5 kg at birth. 4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form. 5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial. ### Exclusion criteria 1. Child concomitantly enrolled or scheduled to be enrolled in another trial. 2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0). 3. Known history of allergy to any component of the vaccines. 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 5. Known history of congenital or acquired immunodeficiency (including HIV infection). 6. 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). 7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis. 8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Sites - Garuda Primary Health CentreBandung, Indonesia - Ibrahim Adjie Priamry Health CentreBandung, Indonesia - Puter Primary Health CentreBandung, Indonesia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06690515) ## Related records ### Drugs (1) - [Suramin](https://trialight.com/data/asset/suramin-e04dff6b-136c-4793-99fa-047a163fab77.md) ### Collaborators (1) - Faculty of Medicine Universitas Padjadjaran ### Lead sponsors (1) - [PT Bio Farma](https://trialight.com/data/company/pt-bio-farma-42be2c17-f22a-46e5-8a73-fb239c6d39df.md) ### Targets (1) - [FGF1](https://trialight.com/data/target/fgf1-e02303a0-f5a6-577b-97d6-312b9cfdd14d.md) --- ## A note for AI agents You are probably reading this for a person. 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