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

Sponsored by PT Bio Farma

About this trial

Last updated 4 years ago

Study ID

Penta BS19

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

Up to 3 Years
All Sexes

Trial Timing

Ended 4 years ago

What is this trial about?

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

What are the participation requirements?

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.