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

PT Bio Farma

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Biological: tOPV commercial batch

Biological: tOPV pilot batch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02093273

OPV 0213

Details and patient eligibility

About

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

Full description

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

Enrollment

240 patients

Sex

All

Ages

1 minute to 1 day old

Volunteers

Accepts Healthy Volunteers

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