Clinical trial NCT06690515: Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
Official title: Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Vaccine Adverse Reaction
Vaccine Reaction
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Faculty of Medicine Universitas Padjadjaran
First posted: 2024-11-15
Enrollment: 465
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects.

In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses.

The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
timeFrame: From enrollment up to 28 days after third dose
Secondary outcomes:
measure: Phase I: Safety of the vaccine within 28 days after last dose
timeFrame: From enrollment to 28 days after each dose
measure: Phase I: Safety of the vaccine within 6 months after last dose
timeFrame: From enrollment up to 6 months after the last dose
measure: 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
measure: 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
measure: Phase I: Routine laboratory evaluation that probably related to the vaccination
timeFrame: From enrollment to 7 days after first dose
measure: Phase I: Serological response to diphteria toxoid and tetanus toxoid
timeFrame: 28 days after the last dose immunization
measure: Phase I: Serological response to the pertussis component (agglutinins)
timeFrame: 28 days after the last dose immunization
measure: Phase I: Geometric mean of anti-HbsAg
timeFrame: 28 days after the last dose immunization
measure: Phase I: Serological response to Hib/PRP
timeFrame: 28 days after the last dose immunization
measure: Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity)
timeFrame: 28 days after the last dose immunization
measure: Phase II: Serological response to diphtheria toxoid, tetanus toxoid
timeFrame: 28 days after the last dose immunization
measure: Phase II: Serological response to the pertussis component (agglutinins)
timeFrame: 28 days after the last dose immunization
measure: Phase II: Geometric mean of anti-HbsAg
timeFrame: 28 days after the last dose immunization
measure: Phase II: Serological response to Hib/PRP
timeFrame: 28 days after the last dose immunization
measure: Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity)
timeFrame: 28 days after the last dose immunization
measure: Phase II: Safety of vaccine within 30 minutes after immunization
timeFrame: 30 minutes after immunization
measure: Phase II: Safety of vaccine within 7 days after immunization
timeFrame: Within 7 days after immunization
measure: Phase II: Safety of vaccine after 7 days to 28 days following the vaccination
timeFrame: From 7 days to 28 days following the vaccination
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adjie Priamry Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Centre
state: West Java
Study officials:
References: