Phase 2
N=340
Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02894840 ↗Enrolled (actual)
340
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Adverse Events — 5; 8; 69; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- an inactivated influenza vaccine (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 8; 69; 30 | — |
| SECONDARY Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. |
17; 0; 176; 0; 14; 0 | — |
| SECONDARY Geometric Mean of Immune Response at Every Time of Assessment |
21.44; 24.62; 19.39; 20.14; 380.55; 24.62 | — |
| SECONDARY Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer |
17.75; 1.00; 20.25; 0.99; 10.56; 1.00 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02894840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.