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Not yet recruiting NCT06690515

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

Phase I / Phase II Interventional Vaccine Adverse Reaction Vaccine Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B, Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®.
Who it may be relevant to
Registry conditions: Vaccine Adverse Reaction, Vaccine Reaction. Basic parameters: 6 Weeks — 11 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

  • Biological 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.
  • 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.
  • 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

Primary outcome measures

  • Phase I: 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 [Time frame: From enrollment up to 28 days after third dose]
Secondary outcome measures (12)
  • Phase I: Safety of the vaccine within 28 days after last dose [Time frame: From enrollment to 28 days after each dose]
  • Phase I: Safety of the vaccine within 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 [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 [Time frame: From enrollment to 6 months after last dose]
  • Phase I: Routine laboratory evaluation that probably related to the vaccination [Time frame: From enrollment to 7 days after first dose]
  • Phase I: Serological response to diphteria toxoid and tetanus toxoid [Time frame: 28 days after the last dose immunization]
  • Phase I: Serological response to the pertussis component (agglutinins) [Time frame: 28 days after the last dose immunization]
  • Phase I: Geometric mean of anti-HbsAg [Time frame: 28 days after the last dose immunization]
  • Phase I: Serological response to Hib/PRP [Time frame: 28 days after the last dose immunization]
  • Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity) [Time frame: 28 days after the last dose immunization]
  • Phase II: Serological response to diphtheria toxoid, tetanus toxoid [Time frame: 28 days after the last dose immunization]
  • Phase II: Serological response to the pertussis component (agglutinins) [Time frame: 28 days after the last dose immunization]

Eligibility criteria

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.
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  • Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Indonesia · 3 centers
  • Garuda Primary Health Centre — Bandung
  • Ibrahim Adjie Priamry Health Centre — Bandung
  • Puter Primary Health Centre — Bandung

Identifiers

NCT: NCT06690515 · Hexa 010224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗