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

NCT ID: NCT06690515

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-09-30

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.

Conditions

Vaccine Adverse Reaction; Vaccine Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A

0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses

Group Type: EXPERIMENTAL

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A

Intervention Type: BIOLOGICAL

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.

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B

0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses.

Group Type: EXPERIMENTAL

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B

Intervention Type: BIOLOGICAL

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.

Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®

0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses.

Group Type: ACTIVE_COMPARATOR

Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®

Intervention Type: BIOLOGICAL

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

Interventions

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A

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.

Intervention Type: BIOLOGICAL

DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B

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.

Intervention Type: BIOLOGICAL

Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 11 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty of Medicine Universitas Padjadjaran

UNKNOWN

Sponsor Role: collaborator

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Indonesia

Central Contacts

Rini Mulia Sari, MD

Role: CONTACT

rini.mulia@biofarma.co.id

+622033755 ext. 14102

Mita Puspita, MD

Role: CONTACT

mita.puspita@biofarma.co.id

+622033755 ext. 5045

Other Identifiers

Hexa 010224

Identifier Type: -

Identifier Source: org_study_id