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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tOPV commercial batch (Bio Farma)

tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml)

Group Type ACTIVE_COMPARATOR

tOPV commercial batch

Intervention Type BIOLOGICAL

tOPV vaccine is given orally

tOPV pilot batch

tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml)

Group Type EXPERIMENTAL

tOPV pilot batch

Intervention Type BIOLOGICAL

the tOPV vaccine is given orally

Interventions

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tOPV pilot batch

the tOPV vaccine is given orally

Intervention Type BIOLOGICAL

tOPV commercial batch

tOPV vaccine is given orally

Intervention Type BIOLOGICAL

Other Intervention Names

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tOPV (Bio Farma) tOPV (Bio Farma)

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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes