Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)
Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants
1 other identifier
interventional
240
1 country
4
Brief Summary
The objective of this study is to compare the antibody response 30 days after two doses of t OPV
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 healthy
Started May 2013
Shorter than P25 for phase_2 healthy
4 active sites
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
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedMarch 20, 2014
March 1, 2014
8 months
March 19, 2014
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the antibody response 30 days after two doses of tOPV
antibody titer to Polio
30 days
Secondary Outcomes (1)
To asses and compare the safety of tOPV
30 days
Other Outcomes (1)
To describe the antibody response after two doses of tOPV
30 days
Study Arms (2)
tOPV commercial batch (Bio Farma)
ACTIVE COMPARATORtOPV (Bio Farma) one dose correspond to 2 drops (0.1ml)
tOPV pilot batch
EXPERIMENTALtOPV (Bio Farma), one dose correspond to 2 drops (0.1ml)
Interventions
the tOPV vaccine is given orally
tOPV vaccine is given orally
Eligibility Criteria
You may qualify if:
- Healthy, full term, newborns infants
- newborn residing within a relatively short and easily accessible distance A(\<30km) from the study clinic(s) and not planning to travel away during the entire study period
- Infant born after 37 weeks of pregnancy
- Infant weighing 2.5kg or more at birth (birth weight \>= 2.5kg)
- Healthy newborns, with no history of asphyxia or meconium aspiration
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial
- Mother at least elementary school graduate
You may not qualify if:
- Child concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oC
- Newborns requiring hospitalization at birth
- Infant immunized with non-scheduled OPV or IPV during trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
Study Sites (4)
Garuda Primary Health Center
Bandung, West Java, Indonesia
Ibrahim Adjie Primary Health Centre
Bandung, West Java, Indonesia
Padasuka Primary Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Centre
Bandung, West Java, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eddy Fadlyana, MD
Department of Child Health of Medicine Padjadjaran University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 20, 2014
Study Start
May 1, 2013
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
March 20, 2014
Record last verified: 2014-03