NCT02095314

Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine

Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

Summary

Measure antibody persistence prior to booster administration of Pentabio vaccine.

Detailed description

Number and percentage of children with anti diphtheria, titer and anti tetanus titer \>= 0.01 IU/ml, anti HBs \>=10mIU/ml, anti Hib \>=0.15ug/ml prior to booster administration.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Pentavalen	Batch 5010613

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2014-03-24
• Last updated: 2014-12-18

Locations

6 sites across 1 country: Indonesia