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

NCT02894840 | Completed Phase 1 Results DMC

• 1 other identifier: GPO Tri Fluvac Vaccine
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza

Keywords

GPO Tri Fluvac Vaccine; Tri Fluvac Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

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

  90 days

Secondary Outcomes (3)

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

  90 days

• Geometric Mean of Immune Response at Every Time of Assessment

  90 days

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

  90 days

Study Arms (2)

an inactivated influenza vaccine

ACTIVE COMPARATOR

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.

Biological: an inactivated influenza vaccine

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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.

an inactivated influenza vaccine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• The Government Pharmaceutical Organization: collaborator
• World Health Organization: collaborator

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

No limitations

Results Point of Contact

• Title: Prof.Punnee Pitisuttithum
• Organization: Mahidol university

punnee.pit@mahidol.ac.th

662 6435599

Study Officials

• Punnee Pitisuttithum, Prof.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 9, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 17, 2020
• Results First Posted: September 19, 2018

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share