Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
1 other identifier
interventional
600
1 country
6
Brief Summary
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 healthy
Started Aug 2012
Shorter than P25 for phase_3 healthy
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedNovember 18, 2013
October 1, 2013
5 months
October 30, 2013
November 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
Number and percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHBs titer \>=10mlIU/ml, and antiHib titer \>= 0,15ug/ml 28 days after the last injection
4 months
Secondary Outcomes (6)
Antibody response to diphtheria between groups (three different batch numbers)
4 months
Antibody response to Tetanus between groups (three different batch numbers)
4 months
Antibody response to Pertussis component between groups (three different batch numbers)
4 months
Antibody response to Hepatitis B between groups (three different batch numbers)
4 months
Antibody response to Hib/PRP between groups (three different batch numbers)
4 months
- +1 more secondary outcomes
Study Arms (3)
DTP/HB/Hib Vaccine (Batch: A)
EXPERIMENTALPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
DTP/HB/Hib vaccine (Batch: B)
EXPERIMENTALPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
DTP/HB/Hib vaccine (Batch: C)
EXPERIMENTALPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Interventions
DPT/HB/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
- Mother at least graduate from elementary school
- Received Hepatitis B vaccine (Bio Farma) at birth
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 weeks)
- 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 (6)
Jatinegara Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Mampang Prapatan Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Tebet Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Garuda Primary Health Center
Bandung, West Java, Indonesia
Ibrahim Adji Primary Health Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Related Publications (1)
Rusmil K, Gunardi H, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Satari HI, Risan NA, Prasetio D, Tarigan R, Garheni R, Milanti M, Hadinegoro SR, Tanuwidjaja S, Bachtiar NS, Sari RM. The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule. BMC Pediatr. 2015 Dec 19;15:219. doi: 10.1186/s12887-015-0525-2.
PMID: 26686508DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kusnandi Rusmil, PhD
Faculty of Medicine UNPAD
- PRINCIPAL INVESTIGATOR
Hartono Gunardi, PhD
Faculty of Medicine UI
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 18, 2013
Study Start
August 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
November 18, 2013
Record last verified: 2013-10