Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

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: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine

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: Interventional
• Enrollment (Actual): 810
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Percentage of subjects with at least one immediate reaction	Immediate reaction (local reaction or systemic event)	30 minutes after each vaccination
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
Serious adverse event after vaccination	Serious adverse event occurring from inclusion until 28 days after vaccination.	28 days
Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.	Adverse events occuring until 28 days after vaccination	28 days
Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.	Adverse events occuring until 28 days after vaccination	28 days

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Meita Dhamayanti, Hasan Sadikin General Hospital

Publications and helpful links

General Publications

• Dhamayanti M, Tarigan R, Fadlyana E, Prasetyo D, Amalia N, Rusmil VK, Sari RM, Bachtiar NS, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study. Vaccine. 2020 Jan 29;38(5):993-1000. doi: 10.1016/j.vaccine.2019.12.008. Epub 2019 Dec 17.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID 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