Safety of Hib Vaccine (Bio Farma)

November 5, 2013 updated by: PT Bio Farma

Phase 1 Study of Hib Vaccine (Bio Farma)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Hasan Sadikin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (age 18 - 40 years old)
  • Provision of written informed consent
  • Good health according to the clinical investigator
  • Willingness and ability to adhere to the regimen of the study

Exclusion Criteria:

  • Known not enrolled in other study
  • Pregnancy or lactation
  • Known or suspected allergy to any of the vaccine component (by medical history)
  • History of unusual reaction to any previous vaccination
  • Known or suspected immune deficiency, or use of medication that may influence the immune system
  • Prior respiratory infection
  • Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
  • Acute febrile illness (temperature > 37.5 Celsius)
  • Present evidence of serious diseases demanding medical treatment
  • Any significant congenital or chronic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hib/PRP-T vaccine

One dose, correspond to 0.5 ml, composed of:

PRP-T 10ug NaCl 0.85%

Frequency: 1 injection
Biological: Hib/PRP-T vaccine
Hib liquid vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Time Frame: 30 minutes
Local and systemic reactions
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the antibody function serum using serum bactericidal activities test
Time Frame: 28 days
Presence of serum of bactericidal activities after immunization.
28 days
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Time Frame: 28 hours, 48 hours, 72 hours, 28 days
Local and systemic reaction
28 hours, 48 hours, 72 hours, 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hib 0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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