Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336593
• Other study ID #: QIV 0217
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: November 30, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues

Intervention

Biological:
• Quadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
• Trivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Center	Bandung	West Java
Indonesia	Ibrahim Adjie Primary Health Center	Bandung	West Java
Indonesia	Puter Primary Health Center	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with an anti-influenza titer >= 1:40 HI units	The anti-influenza antibody serological response	28 days after the last dose immunization
Secondary	Geometric Mean Titer (GMT)	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
Secondary	Percentage of subjects with increasing antibody titer >= 4 times	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
Secondary	Percentage of subjects with transition of seronegative to seropositive	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
Secondary	Percentage of subjects with at least one immediate reaction	Immediate reaction (local reaction or systemic event)	30 minutes after each vaccination
Secondary	Percentage of subjects with at least one of these adverse events	At least one of these adverse events, expected or not	within 72 hours, between 72 hours to 28 days after vaccination
Secondary	Serious adverse event after vaccination	Serious adverse event occurring from inclusion until 28 days after vaccination.	28 days
Secondary	Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.	Adverse events occuring until 28 days after vaccination	28 days
Secondary	Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.	Adverse events occuring until 28 days after vaccination	28 days