Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

April 27, 2015 updated by: PT Bio Farma

Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children

To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 2
  • Phase 3

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
      • Jakarta, Indonesia
        • Jatinegara Primary Health Center
      • Jakarta, Indonesia
        • Primary School of SDN 01 Kampung Melayu

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

6 months to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Parents have been informed properly regarding the study and signed the informed consent form
  • Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

  • Subjects concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature >=37oC)
  • Known history of allergy to egg and/or chicken protein or any other component of the vaccines
  • Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (>2 weeks)).
  • Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
  • Subjects has been immunized with influenza vaccine within 1 year
  • Subjects receives any vaccination within 1 months before and after immunization of Flubio.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine

Vaccine

Flubio (Influenza HA) vaccine

2 doses for infants and children (6 months - 8 years old)

1 doses for children (9-11 years old)

The vaccine will be given intramuscularly
Biological: Vaccine

Flubio (Influenza HA) Vaccine

The vaccine will be given intramuscularly.

Other Names:
  • Flubio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
Time Frame: 2 months
Percentage of subjects with anti HI titer >=1:40
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)
Time Frame: 2 months
Percentage subjects with increasing antibody titer >=4 times
2 months
To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)
Time Frame: 1 months
Percentage of subjects with transition of seronegative to seropositive
1 months
To asses the safety of Flubio vaccine
Time Frame: 1-2 months
Local and Systemic Reaction following immunization
1-2 months

Collaborators and Investigators

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

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Bernie Endyarni, MD, Department of Child Health, School of Medicine, University of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Influenza 0213

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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