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Completed

NCT Number: NCT02894840

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

an inactivated influenza vaccine

Biological

The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Placebo

Other

The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 90 days

    All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine

Secondary outcomes

  1. Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.

    Time frame: 90 days

    Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.

  2. Geometric Mean of Immune Response at Every Time of Assessment

    Time frame: 90 days

    The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90)

  3. Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer

    Time frame: 90 days

    The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • The Government Pharmaceutical Organization
  • World Health Organization

Registry information

Official study title

A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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