Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)

Study Overview
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Brief Summary
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The objective of this study is to compare the antibody response 30 days after two doses of t OPV

Detailed Description
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The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: tOPV pilot batch
* Biological: tOPV commercial batch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tOPV commercial batch (Bio Farma)<br>tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml) | Biological: tOPV commercial batch<br>* tOPV vaccine is given orally<br>* Other names: tOPV (Bio Farma);|
| Experimental: tOPV pilot batch<br>tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml) | Biological: tOPV pilot batch<br>* the tOPV vaccine is given orally<br>* Other names: tOPV (Bio Farma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the antibody response 30 days after two doses of tOPV | antibody titer to Polio | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses and compare the safety of tOPV | Data collection of local and systemic reaction after immunization | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tOPV, Antibody response, Safety