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
Summary
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.
Eligibility
Minimum age: 6 Weeks.
Maximum age: 11 Weeks.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hasan Sadikin Hospital, Bandung, West Java 40161, Indonesia
Additional Information
Starting date: April 2011
Last updated: November 5, 2013
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