The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 6, 2013
CompletedNovember 6, 2013
October 1, 2013
3 months
October 30, 2013
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reactions
30 minutes
Secondary Outcomes (2)
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
28 hours, 48 hours, 72 hours, 28 days
To asses the immunogenicity
28 days
Study Arms (1)
DTP/HepatitisB/Hib vaccine
EXPERIMENTALPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Interventions
DPT/HepatitisB/Hib vaccine (Bio Farma)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
Study Sites (1)
Hasan Sadikin Hospital
Bandung, West Java, 40161, Indonesia
Study Officials
- PRINCIPAL INVESTIGATOR
Kusnandi Rusmil, PhD
Faculty of Medicine UNPAD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 6, 2013
Study Start
April 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
November 6, 2013
Record last verified: 2013-10