Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

PT Bio Farma

Status and phase: Completed; Phase 2

Conditions: Safety Issues

Treatments: Biological: Trivalent Influenza Vaccine; Biological: Quadrivalent Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03336593

QIV 0217

Details and patient eligibility

About

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

Full 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

Enrollment: 810 patients

Sex: All

Ages: 6 months to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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810 participants in 6 patient groups

QIV batch 1

Experimental group

Description:

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1

Treatment:

Biological: Quadrivalent Influenza Vaccine

QIV batch 2

Experimental group

Description:

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2

Treatment:

Biological: Quadrivalent Influenza Vaccine

QIV batch 3

Experimental group

Description:

1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3

Treatment:

Biological: Quadrivalent Influenza Vaccine

Trivalent Influenza Vaccine

Active Comparator group

Description:

1 dose of 0.5 ml of trivalent influenza vaccine

Treatment:

Biological: Trivalent Influenza Vaccine

QIV (subjects 6-35 months)

Experimental group

Description:

2 dose of 0.25 ml of quadrivalent influenza vaccine

Treatment:

Biological: Quadrivalent Influenza Vaccine

QIV (subjects 3-8 years)

Experimental group

Description:

2 dose of 0.5 ml of quadrivalent influenza vaccine

Treatment:

Biological: Quadrivalent Influenza Vaccine