Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-11-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

The study for subjects 9-40 years of age is randomized, double blind study. While the study for subjects 6 months-8 years of age is open labeled study.

Study Groups

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QIV batch 1

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

QIV batch 2

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

QIV batch 3

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

Trivalent Influenza Vaccine

1 dose of 0.5 ml of trivalent influenza vaccine

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine

QIV (subjects 6-35 months)

2 dose of 0.25 ml of quadrivalent influenza vaccine

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

QIV (subjects 3-8 years)

2 dose of 0.5 ml of quadrivalent influenza vaccine

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

Interventions

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Quadrivalent Influenza Vaccine

1 or 2 doses of Quadrivalent Influenza Vaccine depends on age

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine

1 dose of Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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QIV TIV

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes