Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV … (NCT06690515) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
Indonesia465 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range6 Weeks – 11 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
✕. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.
What they're measuring
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
2
Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
Timeframe: From enrollment up to 28 days after third dose