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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093273

Enrollment

240

Registered

2014-03-20

Start date

2013-05-31

Completion date

2014-02-28

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

tOPV, Antibody response, Safety

Brief summary

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

Detailed description

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

Interventions

BIOLOGICALtOPV pilot batch

the tOPV vaccine is given orally

BIOLOGICALtOPV commercial batch

tOPV vaccine is given orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 1 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To compare the antibody response 30 days after two doses of tOPV	30 days	antibody titer to Polio

Secondary

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

Other

Measure	Time frame	Description
To describe the antibody response after two doses of tOPV	30 days	Measurement of titer antibody

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026