Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

Mahidol University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Other: Placebo; Biological: an inactivated influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02894840

GPO Tri Fluvac Vaccine

Details and patient eligibility

About

The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

Full description

This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be given in both Phase I and Phase II of the study.

The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.

Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.

Enrollment: 340 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Age 18-49 years old
• Having Thai ID card or equivalent
• All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
• Able to read and write and sign written informed consent form or assent form.

Exclusion criteria

• Known history of egg allergy
• Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial
• Vaccination against influenza in the past 6 months preceding enrolment to the trial
• History of bronchial asthma, chronic lung diseases, chronic rhinitis
• History of immunodeficiency state
• History of immunosuppression < 6 months prior to immunization
• History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal)
• Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial
• The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment
• Participation in other research study
• Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
• Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups, including a placebo group

an inactivated influenza vaccine

Active Comparator group

Description:

20 volunteers in phase I study and 200 volunteers in phase II study will receive a single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Treatment:

Biological: an inactivated influenza vaccine

Placebo

Placebo Comparator group

Description:

20 volunteers in phase I study and 100 volunteers in phase II study will receive a single dose of placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Treatment:

Other: Placebo