- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977196
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
November 5, 2013 updated by: PT Bio Farma
Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Java
-
Bandung, West Java, Indonesia, 40161
- Hasan Sadikin Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DTP/HepatitisB/Hib vaccine
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
|
DPT/HepatitisB/Hib vaccine (Bio Farma)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Time Frame: 30 minutes
|
Local and systemic reactions
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Time Frame: 28 hours, 48 hours, 72 hours, 28 days
|
Local and systemic reaction
|
28 hours, 48 hours, 72 hours, 28 days
|
To asses the immunogenicity
Time Frame: 28 days
|
Percentage of infants with increasing antibody
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (Estimate)
November 6, 2013
Study Record Updates
Last Update Posted (Estimate)
November 6, 2013
Last Update Submitted That Met QC Criteria
November 5, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Penta 0111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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