Status:
COMPLETED
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
Lead Sponsor:
PT Bio Farma
Conditions:
Healthy
Eligibility:
All Genders
1-1 years
Phase:
PHASE4
Brief Summary
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit
Detailed Description
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simulta...
Eligibility Criteria
Inclusion
- Healthy, full term, newborns infants.
- Newborns residing within a relatively short and easily accessible distance (\<30 km) 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 2.5 kg or more at birth (Birth weight \> 2.5 kg)
- 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
Exclusion
- 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 ≥ 37.5°C )
- Newborns requiring hospitalization at birth.
- Infant immunized with non-scheduled bOPV or IPV during trial
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03310073
Start Date
July 1 2016
End Date
March 1 2017
Last Update
November 8 2017
Active Locations (1)
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1
Hasan Sadikin Hospital
Bandung, West Java, Indonesia, 40161