Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants

NCT06690515
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Phase
Phase 1/Phase 2
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Recruitment status
Not yet recruiting
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Participants
465
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Lead sponsor
PT Bio Farma
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Start date
2025-03-01
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Number of sites
3
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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.
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Short title
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
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Official title
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2026-09-30
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First posted
2024-11-15
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Registry last updated
2024-11-15
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Primary completion date
2025-10-31
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Start date
2025-03-01
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Participants
465
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Participant count basis
Estimated
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Planned participants
465
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Protocol amendments
0
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Number of sites
3
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
PT Bio Farma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06690515
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ClinicalTrials.gov ID
NCT06690515
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
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  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

  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
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Sex
All
Age groups
Children
Minimum age
6 Weeks
Maximum age
11 Weeks
Healthy volunteers
Yes

  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.

  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
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  • Garuda Primary Health CentreBandung, Indonesia
  • Ibrahim Adjie Priamry Health CentreBandung, Indonesia
  • Puter Primary Health CentreBandung, Indonesia
Sources for sites
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)