Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-12-16

Brief Summary

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Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

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Detailed Description

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Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants

Conditions

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Immunogenicity Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product

Study Groups

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HepB + Penta batch 1

Recombinant Hepatitis B + DTP-HB-Hib batch 1

Group Type EXPERIMENTAL

Recombinant Hepatitis B + DTP-HB-Hib

Intervention Type BIOLOGICAL

1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib

Hep B + Pentabio (registered)

Recombinant Hepatitis B + Pentabio (registered)

Group Type ACTIVE_COMPARATOR

Hep B + Pentabio (registered)

Intervention Type BIOLOGICAL

1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

Interventions

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Recombinant Hepatitis B + DTP-HB-Hib

1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib

Intervention Type BIOLOGICAL

Hep B + Pentabio (registered)

1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

Intervention Type BIOLOGICAL

Other Intervention Names

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Hep B + DTP-HB-Hib Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)

Eligibility Criteria

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Inclusion Criteria

* Healthy, full term, newborns infants.
* Infant born after 37-42 weeks of pregnancy.
* Infant weighing 2500 gram or more at birth.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

Exclusion Criteria

* Child concomitantly enrolled or scheduled to be enrolled in another trial.
* Mother with HBsAg positive.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5C on Day 0).
* Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
* Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
* Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
* Received other vaccination 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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes