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

ConditionsVaccine Adverse ReactionVaccine Reaction
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-11
SponsorPT Bio Farma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Biological/Vaccine

    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

    Biological/Vaccine

    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/Vaccine

    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

Treatment groups

465 Participants
are divided into 3 treatment groups
Group A: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula AExperimental treatment 1 intervention
Group B: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula BExperimental treatment 1 intervention
Group C: Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PT Bio Farma

Lead sponsor

Faculty of Medicine Universitas Padjadjaran

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: