The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

November 5, 2013 updated by: PT Bio Farma

Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine

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

Study Overview

Status

Completed

Conditions

Detailed Description

This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Study Type

Interventional

Enrollment (Actual)

30

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

    • 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

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infant 6-11 week of age
  • Infant born after 37-42 week of pregnancy
  • Infant weighting more than 2.5 kg at birth
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
  • Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion Criteria:

  • Child concomitantly enroll or schedule to be enroll in another trial
  • Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
  • Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
  • History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
  • Known history of congenital or acquired immunodeficiency (including HIV infection)
  • Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
  • Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
  • Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTP/HepatitisB/Hib vaccine
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
DPT/HepatitisB/Hib vaccine (Bio Farma)
Other Names:
  • Pentavalent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse event of DTP/Hepatitis B/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
To asses the immunogenicity
Time Frame: 28 days
Percentage of infants with increasing antibody
28 days

Collaborators and Investigators

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

Sponsor

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

April 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 30, 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

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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