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

Information source: PT Bio Farma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: DPT/HepatitisB/Hib vaccine (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: PT Bio Farma

Official(s) and/or principal investigator(s):
Kusnandi Rusmil, PhD, Principal Investigator, Affiliation: Faculty of Medicine UNPAD


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.

Clinical Details

Official title: Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)

Secondary outcome:

Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)

To asses the immunogenicity

Detailed 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.


Minimum age: 6 Weeks. Maximum age: 11 Weeks. Gender(s): Both.


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


- 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


- 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


Locations and Contacts

Hasan Sadikin Hospital, Bandung, West Java 40161, Indonesia
Additional Information

Starting date: April 2011
Last updated: November 5, 2013

Page last updated: August 23, 2015

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