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

Phase 2Not Yet RecruitingNCT06690515

PT Bio Farma465 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

465

Conditions

Vaccine Adverse Reaction Vaccine Reaction

Interventions

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

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 BBIOLOGICAL

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)®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

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 11 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose

Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose

Time frame: From enrollment to 7 days after first dose

Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine

Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine

Time frame: From enrollment up to 28 days after third dose

Secondary Outcomes

Phase I: Safety of the vaccine within 28 days after last dose

Number and percentage of solicited and unsolicited adverse events within 28 days after each dose

Time frame: From enrollment to 28 days after each dose

Phase I: Safety of the vaccine within 6 months after last dose

Number and percentage of subjects with serious adverse events until 6 months after last dose

Time frame: From enrollment up to 6 months after the last dose

Phase I: Comparison of safety within 28 days after each dose between vaccines and active control

Comparison of number and percentage of subjects with adverse events between vaccine and control group within 28 days after each dose

Time frame: From enrollment to 28 days after each dose

Phase I: Comparison of safety until 6 months after last dose between vaccines and active control

Comparison of number and percentage of subjects with serious adverse events between vaccine and control group until 6 months after last dose

Time frame: From enrollment to 6 months after last dose

Central Contacts

Rini Mulia Sari, MD

CONTACT

+622033755 rini.mulia@biofarma.co.id

Mita Puspita, MD

CONTACT

+622033755 mita.puspita@biofarma.co.id

Data from ClinicalTrials.gov

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