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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093273
• Other study ID #: OPV 0213
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2014
• Last updated: March 19, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• tOPV pilot batch
the tOPV vaccine is given orally
• tOPV commercial batch
tOPV vaccine is given orally

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Center	Bandung	West Java
Indonesia	Ibrahim Adjie Primary Health Centre	Bandung	West Java
Indonesia	Padasuka Primary Health Centre	Bandung	West Java
Indonesia	Puter Primary Health Centre	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To describe the antibody response after two doses of tOPV	Measurement of titer antibody	30 days	No
Primary	To compare the antibody response 30 days after two doses of tOPV	antibody titer to Polio	30 days	No
Secondary	To asses and compare the safety of tOPV	Data collection of local and systemic reaction after immunization	30 days	Yes