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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Biological: tOPV commercial batch; Biological: tOPV pilot batch

• Registration Number: NCT02093273
• Lead Sponsor: PT Bio Farma

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tOPV commercial batch (Bio Farma)	tOPV commercial batch	tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml)
tOPV pilot batch	tOPV pilot batch	tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml)

Primary Outcome Measures

Name	Time	Method
To compare the antibody response 30 days after two doses of tOPV	30 days	antibody titer to Polio

Secondary Outcome Measures

Name	Time	Method
To asses and compare the safety of tOPV	30 days	Data collection of local and systemic reaction after immunization

Trial Locations

Locations (4)

Ibrahim Adjie Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia

Garuda Primary Health Center; 🇮🇩 Bandung, West Java, Indonesia

Puter Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia

Padasuka Primary Health Centre; 🇮🇩 Bandung, West Java, Indonesia