Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

April 1, 2019 updated by: PT Bio Farma

A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population.

To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
810

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
        • Garuda Primary Health Center
      • Bandung, West Java, Indonesia
        • Ibrahim Adjie Primary Health Center
      • Bandung, West Java, Indonesia
        • Puter Primary Health Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for Subjects 9 - 40 Years of Age:

  • Healthy
  • Properly informed about the study and having signed the informed consent form
  • Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Inclusion Criteria for Subjects 6 Months - 8 Years of Age:

  • 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:

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >= 37.5 C )
  • Known history of allergy to egg and or chicken protein or any component of the vaccines
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
  • Pregnancy & Lactation (Adult)
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
  • Subject already immunized with influenza vaccine within 1 year.
  • Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QIV batch 1
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1
Biological: Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other Names:
  • QIV
Experimental: QIV batch 2
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2
Biological: Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other Names:
  • QIV
Experimental: QIV batch 3
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3
Biological: Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other Names:
  • QIV
Active Comparator: Trivalent Influenza Vaccine
1 dose of 0.5 ml of trivalent influenza vaccine
Biological: Trivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine
Other Names:
  • TIV
Experimental: QIV (subjects 6-35 months)
2 dose of 0.25 ml of quadrivalent influenza vaccine
Biological: Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other Names:
  • QIV
Experimental: QIV (subjects 3-8 years)
2 dose of 0.5 ml of quadrivalent influenza vaccine
Biological: Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other Names:
  • QIV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects with an anti-influenza titer >= 1:40 HI units
Time Frame: 28 days after the last dose immunization
The anti-influenza antibody serological response
28 days after the last dose immunization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT)
Time Frame: 28 days
GMT in all subjects; comparison of GMT between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison of GMT between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
28 days
Percentage of subjects with increasing antibody titer >= 4 times
Time Frame: 28 days
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
28 days
Percentage of subjects with transition of seronegative to seropositive
Time Frame: 28 days
Percentage of subjects with transition of seronegative to seropositive: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
28 days
Percentage of subjects with at least one immediate reaction
Time Frame: 30 minutes after each vaccination
Immediate reaction (local reaction or systemic event)
30 minutes after each vaccination
Percentage of subjects with at least one of these adverse events
Time Frame: within 72 hours, between 72 hours to 28 days after vaccination
At least one of these adverse events, expected or not
within 72 hours, between 72 hours to 28 days after vaccination
Serious adverse event after vaccination
Time Frame: 28 days
Serious adverse event occurring from inclusion until 28 days after vaccination.
28 days
Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.
Time Frame: 28 days
Adverse events occuring until 28 days after vaccination
28 days
Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.
Time Frame: 28 days
Adverse events occuring until 28 days after vaccination
28 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PT Bio Farma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meita Dhamayanti, Hasan Sadikin General Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QIV 0217

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Safety Issues

Clinical Trials on Quadrivalent Influenza Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings