Influenza
Conditions
Keywords
GPO Tri Fluvac Vaccine, Tri Fluvac vaccine
Brief summary
The study is aim to evaluate the immunogenicity and safety with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine
Detailed description
This is a phase II/III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity and safety with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine). A total of about 945 healthy Thai male and female adult volunteers 18 through 49 years of age; 630 participants will be randomized to receive the GPO Tri Fluvac and 315 will receive an active comparator (a 2:1 ratio) (inclusion of \ 7% lost to follow-up). Safety will be assessed for all participants through Day 90 after vaccination. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 586 individuals randomized to study vaccine and 293 active comparator vaccine recipients.
Interventions
BIOLOGICALGPO Tri Fluvac vaccine
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
BIOLOGICALLicensed influenza vaccine
The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Sponsors
The Government Pharmaceutical Organization
World Health Organization
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded
Intervention model description
non-inferiority double-blinded, randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-49 years old on the day of screening, having Thai ID card or equivalent * Able to read and write in Thai and sign written informed consent form * Able to attend all scheduled visits and to comply with all trial procedures. * Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination. * For female participants: * Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day 60. * Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than one year must be willing to use effective contraceptive method to prevent pregnancy until Day 60 after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator
Exclusion criteria
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study. * Hypersensitivity after previous administration of any vaccine. * Having a history of H1N1, H3N2 or Flu B infection within 3 months preceding enrollment to the trial * Vaccination against influenza in the past 6 months preceding enrollment to the trial * Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 21 visit. * 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) * History of Guillain-Barré Syndrome. * Having acute infection with fever \> 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial * Volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 21 visit. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | pre-vaccination (Day 0), 21 days post-vaccination | Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria. Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21. Measured against each of the 3 antigens |
| Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | pre-vaccination (Day 0), 21 days post-vaccination | Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens. Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as \< 10) will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit. |
| Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | 30-minutes period,day 1,day 2 and day 3 post-vaccination period | Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination. Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis |
| Number of Participants With Unsolicited Adverse Events. | within 90 days post-vaccination | Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated. |
Countries
Thailand
Participant flow
Recruitment details
An advertising brochure on this study which was approved by the Institutional Review Board (IRB) was distributed to potential participants. Participants who were interested in participating in this study contacted the investigator. An appointment was made to explain the details of the study individually.
Pre-assignment details
Pre-assignment Details A total of 945 participants who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| GPO Tri Fluvac Vaccine 630 volunteers will receive a single dose of the seasonal trivalent inactivated influenza vaccine (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) produced by GPO Thailand. To be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
GPO Tri Fluvac vaccine: The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | 630 |
| Licensed Influenza Vaccine 315 volunteers will receive acLicensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2017 (consisting of A/Michigan/45/2015 (H1N1)pdm-09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.
Licensed influenza vaccine: The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | 315 |
| Total | 945 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 4 |
| Overall Study | Move from study area | 3 | 2 |
| Overall Study | Move to work oversea | 0 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | To drug therapy course | 0 | 1 |
| Overall Study | To militarycamp for conscript | 1 | 0 |
Baseline characteristics
| Characteristic | Licensed Influenza Vaccine | Total | GPO Tri Fluvac Vaccine |
|---|---|---|---|
| Age, Continuous | 29.32 years STANDARD_DEVIATION 9.34 | 29.28 years STANDARD_DEVIATION 9.38 | 29.26 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Thais | 315 Participants | 945 Participants | 630 Participants |
| Region of Enrollment Thailand | 315 Participants | 945 Participants | 630 Participants |
| Sex: Female, Male Female | 180 Participants | 541 Participants | 361 Participants |
| Sex: Female, Male Male | 135 Participants | 404 Participants | 269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 630 | 1 / 315 |
| other Total, other adverse events | 273 / 630 | 114 / 315 |
| serious Total, serious adverse events | 1 / 630 | 1 / 315 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens. Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as \< 10) will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit.
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Population: Geometric mean titer against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants. The analysis was performed as intention-to-treat (ITT).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H1 at Day 0 | 40.67 titer |
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H1 at Day 21 | 326.09 titer |
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H3 at Day 0 | 45.55 titer |
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H3 at Day 21 | 349.30 titer |
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu B at Day 0 | 18.00 titer |
| GPO Tri Fluvac Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu B at Day 21 | 165.96 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu B at Day 0 | 19.27 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H1 at Day 0 | 42.82 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H3 at Day 21 | 297.38 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H1 at Day 21 | 459.64 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu B at Day 21 | 139.72 titer |
| Licensed Influenza Vaccine | Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination | GMT Flu A H3 at Day 0 | 45.35 titer |
Primary
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria. Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21. Measured against each of the 3 antigens
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Population: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants. The analysis was performed as intention-to-treat (ITT).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GPO Tri Fluvac Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu A H1 at Day 21 | 413 Participants |
| GPO Tri Fluvac Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu A H3 at Day 21 | 411 Participants |
| GPO Tri Fluvac Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu B at Day 21 | 425 Participants |
| Licensed Influenza Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu A H3 at Day 21 | 201 Participants |
| Licensed Influenza Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu A H1 at Day 21 | 216 Participants |
| Licensed Influenza Vaccine | Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination | Seroconversion Flu B at Day 21 | 199 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.
Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination. Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis
Time frame: 30-minutes period,day 1,day 2 and day 3 post-vaccination period
Population: The analysis was conducted for participants who were randomized and received a study vaccination. Analysis based on Intention to Treat Analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 2 | 7 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 2 | 11 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 3 | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, 30 min | 8 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, 30 min | 11 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, Day 2 | 38 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 1 | 61 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 1 | 60 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 2 | 23 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 3 | 2 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 3 | 15 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 2 | 26 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, 30 min | 5 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, 30 min | 52 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 1 | 18 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 3 | 16 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 2 | 11 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, 30 min | 6 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 3 | 5 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, 30 min | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, 30 min | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, Day 1 | 144 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 1 | 6 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 1 | 50 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 2 | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 1 | 42 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 3 | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 2 | 20 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, 30 min | 0 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 1 | 64 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 1 | 0 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 3 | 17 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 2 | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 2 | 25 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 3 | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, 30 min | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, 30 min | 0 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain,Day 3 | 7 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 1 | 5 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 1 | 12 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 2 | 6 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 3 | 11 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 3 | 2 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, 30 min | 115 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 3 | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, 30 min | 30 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, Day 1 | 88 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain, Day 2 | 28 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Pain,Day 3 | 6 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, 30 min | 14 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 1 | 25 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 2 | 10 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Limitation of arm movement, Day 3 | 2 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, 30 min | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 1 | 20 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 2 | 12 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Headache, Day 3 | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, 30 min | 4 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 1 | 36 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 2 | 15 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Fatigue, Day 3 | 6 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, 30 min | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 1 | 24 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 2 | 7 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Malaise, Day 3 | 4 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, 30 min | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 1 | 4 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 2 | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Chills, Day 3 | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, 30 min | 12 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 1 | 34 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 2 | 16 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Myalgia, Day 3 | 8 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, 30 min | 4 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 1 | 10 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 2 | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Arthralgia, Day 3 | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, 30 min | 2 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 1 | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 2 | 2 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Nausea, Day 3 | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, 30 min | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 1 | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 2 | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Vomiting, Day 3 | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, 30 min | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 1 | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. | Rash, Day 2 | 0 Participants |
Primary
Number of Participants With Unsolicited Adverse Events.
Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.
Time frame: within 90 days post-vaccination
Population: The analysis was conducted for participants who were randomized and received a study vaccination by Intention to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Headache | 40 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Influenza like Illness (ILI) | 7 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Pyrexia | 24 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Influenza | 2 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Pharyngitis | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Tonsillitis | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Tonsillitis bacterial | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Upper respiratory tract infection | 111 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Arthralgia | 1 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Myalgia | 5 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Dizziness | 4 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Cough | 12 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Productive cough | 2 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Rhinitis | 5 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Rhinorrhoea | 27 Participants |
| GPO Tri Fluvac Vaccine | Number of Participants With Unsolicited Adverse Events. | Sneezing | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Sneezing | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Headache | 16 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Arthralgia | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Influenza like Illness (ILI) | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Productive cough | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Pyrexia | 12 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Myalgia | 3 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Influenza | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Rhinorrhoea | 6 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Pharyngitis | 1 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Dizziness | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Tonsillitis | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Rhinitis | 2 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Tonsillitis bacterial | 0 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Cough | 4 Participants |
| Licensed Influenza Vaccine | Number of Participants With Unsolicited Adverse Events. | Upper respiratory tract infection | 44 Participants |