The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
DPT/HepatitisB/Hib vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring DTB/HB/Hib vaccine, Infants, Phase I
Eligibility 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
Sites / Locations
- Hasan Sadikin Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DTP/HepatitisB/Hib vaccine
Arm Description
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Outcomes
Primary Outcome Measures
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reactions
Secondary Outcome Measures
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reaction
To asses the immunogenicity
Percentage of infants with increasing antibody
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01977196
Brief Title
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Official Title
Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
DTB/HB/Hib vaccine, Infants, Phase I
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DTP/HepatitisB/Hib vaccine
Arm Type
Experimental
Arm Description
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Intervention Type
Biological
Intervention Name(s)
DPT/HepatitisB/Hib vaccine
Other Intervention Name(s)
Pentavalent
Intervention Description
DPT/HepatitisB/Hib vaccine (Bio Farma)
Primary Outcome Measure Information:
Title
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Description
Local and systemic reactions
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Description
Local and systemic reaction
Time Frame
28 hours, 48 hours, 72 hours, 28 days
Title
To asses the immunogenicity
Description
Percentage of infants with increasing antibody
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kusnandi Rusmil, PhD
Organizational Affiliation
Faculty of Medicine UNPAD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Sadikin Hospital
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
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