Clinical Trials Directory

Trials / Completed

CompletedNCT01977170

Safety of Hib Vaccine (Bio Farma)

Phase 1 Study of Hib Vaccine (Bio Farma)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
25 (actual)
Sponsor
PT Bio Farma · Industry
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed description

This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Conditions

Interventions

TypeNameDescription
BIOLOGICALHib/PRP-T vaccineHib liquid vaccine

Timeline

Start date
2010-11-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2013-11-06
Last updated
2013-11-06

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT01977170. Inclusion in this directory is not an endorsement.