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

PT Bio Farma

Status and phase

Completed

Phase 3

Conditions

Safety

Immunogenicity

Treatments

Biological: Hep B + Pentabio (registered)

Biological: Recombinant Hepatitis B + DTP-HB-Hib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04071379

Penta BS19

Details and patient eligibility

About

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

Full description

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

Enrollment

220 patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

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.