The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

PT Bio Farma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: DPT/HepatitisB/Hib vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01977196

Penta 0111

Details and patient eligibility

About

The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Full description

This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Enrollment

30 patients

Sex

All

Ages

6 to 11 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infant 6-11 week of age
Infant born after 37-42 week of pregnancy
Infant weighting more than 2.5 kg at birth
Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion criteria

Child concomitantly enroll or schedule to be enroll in another trial
Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
Known history of congenital or acquired immunodeficiency (including HIV infection)
Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
Other vaccination within the 7 days prior to inclusion 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 objective
Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection