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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 4 years ago
What is this trial about?
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.
