Trial Outcomes & Findings for Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults (NCT NCT03390166)

Last Updated: 2020-04-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

945 participants

Primary outcome timeframe

pre-vaccination (Day 0), 21 days post-vaccination

Results posted on

2020-04-14

Participant Flow

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 A total of 945 participants who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	630	315
Overall Study COMPLETED	618	305
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	0	1
Overall Study Lost to Follow-up	6	4
Overall Study Physician Decision	2	1
Overall Study Move from study area	3	2
Overall Study To militarycamp for conscript	1	0
Overall Study To drug therapy course	0	1
Overall Study Move to work oversea	0	1

Baseline Characteristics

Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GPO Tri Fluvac Vaccine n=630 Participants 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.	Licensed Influenza Vaccine n=315 Participants 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.	Total n=945 Participants Total of all reporting groups
Age, Continuous	29.26 years STANDARD_DEVIATION 9.40 • n=5 Participants	29.32 years STANDARD_DEVIATION 9.34 • n=7 Participants	29.28 years STANDARD_DEVIATION 9.38 • n=5 Participants
Sex: Female, Male Female	361 Participants n=5 Participants	180 Participants n=7 Participants	541 Participants n=5 Participants
Sex: Female, Male Male	269 Participants n=5 Participants	135 Participants n=7 Participants	404 Participants n=5 Participants
Race/Ethnicity, Customized Thais	630 Participants n=5 Participants	315 Participants n=7 Participants	945 Participants n=5 Participants
Region of Enrollment Thailand	630 Participants n=5 Participants	315 Participants n=7 Participants	945 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	GPO Tri Fluvac Vaccine n=630 Participants 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.	Licensed Influenza Vaccine n=315 Participants 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.
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination Seroconversion Flu A H1 at Day 21	413 Participants	216 Participants
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination Seroconversion Flu A H3 at Day 21	411 Participants	201 Participants
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination Seroconversion Flu B at Day 21	425 Participants	199 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	GPO Tri Fluvac Vaccine n=630 Participants 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.	Licensed Influenza Vaccine n=315 Participants 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.
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu A H1 at Day 0	40.67 titer Interval 36.46 to 45.36	42.82 titer Interval 36.78 to 49.86
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu A H1 at Day 21	326.09 titer Interval 300.1 to 354.34	459.64 titer Interval 405.05 to 521.59
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu A H3 at Day 0	45.55 titer Interval 41.04 to 50.54	45.35 titer Interval 39.09 to 52.6
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu A H3 at Day 21	349.30 titer Interval 317.79 to 383.93	297.38 titer Interval 261.48 to 338.21
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu B at Day 0	18.00 titer Interval 16.27 to 19.9	19.27 titer Interval 16.71 to 22.21
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination GMT Flu B at Day 21	165.96 titer Interval 151.37 to 181.97	139.72 titer Interval 123.23 to 158.42

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	GPO Tri Fluvac Vaccine n=630 Participants 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.	Licensed Influenza Vaccine n=315 Participants 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.
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Rash, Day 3	2 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Pain, 30 min	115 Participants	30 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Pain, Day 1	144 Participants	88 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Pain, Day 2	38 Participants	28 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Pain,Day 3	7 Participants	6 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Limitation of arm movement, 30 min	52 Participants	14 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Limitation of arm movement, Day 1	64 Participants	25 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Limitation of arm movement, Day 2	11 Participants	10 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Limitation of arm movement, Day 3	2 Participants	2 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Headache, 30 min	6 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Headache, Day 1	42 Participants	20 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Headache, Day 2	25 Participants	12 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Headache, Day 3	11 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Fatigue, 30 min	8 Participants	4 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Fatigue, Day 1	60 Participants	36 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Fatigue, Day 2	26 Participants	15 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Fatigue, Day 3	16 Participants	6 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Malaise, 30 min	4 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Malaise, Day 1	50 Participants	24 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Malaise, Day 2	20 Participants	7 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Malaise, Day 3	17 Participants	4 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Chills, 30 min	4 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Chills, Day 1	12 Participants	4 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Chills, Day 2	7 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Chills, Day 3	4 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Myalgia, 30 min	11 Participants	12 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Myalgia, Day 1	61 Participants	34 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Myalgia, Day 2	23 Participants	16 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Myalgia, Day 3	15 Participants	8 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Arthralgia, 30 min	5 Participants	4 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Arthralgia, Day 1	18 Participants	10 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Arthralgia, Day 2	11 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Arthralgia, Day 3	5 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Nausea, 30 min	1 Participants	2 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Nausea, Day 1	6 Participants	3 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Nausea, Day 2	4 Participants	2 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Nausea, Day 3	1 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Vomiting, 30 min	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Vomiting, Day 1	0 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Vomiting, Day 2	1 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Vomiting, Day 3	1 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Rash, 30 min	0 Participants	0 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Rash, Day 1	5 Participants	1 Participants
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination. Rash, Day 2	6 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.

Outcome measures

Outcome measures
Measure	GPO Tri Fluvac Vaccine n=630 Participants 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.	Licensed Influenza Vaccine n=315 Participants 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.
Number of Participants With Unsolicited Adverse Events. Productive cough	2 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Influenza like Illness (ILI)	7 Participants	3 Participants
Number of Participants With Unsolicited Adverse Events. Pyrexia	24 Participants	12 Participants
Number of Participants With Unsolicited Adverse Events. Influenza	2 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Pharyngitis	4 Participants	1 Participants
Number of Participants With Unsolicited Adverse Events. Tonsillitis	4 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Tonsillitis bacterial	1 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Upper respiratory tract infection	111 Participants	44 Participants
Number of Participants With Unsolicited Adverse Events. Arthralgia	1 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Myalgia	5 Participants	3 Participants
Number of Participants With Unsolicited Adverse Events. Dizziness	4 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events. Headache	40 Participants	16 Participants
Number of Participants With Unsolicited Adverse Events. Cough	12 Participants	4 Participants
Number of Participants With Unsolicited Adverse Events. Rhinitis	5 Participants	2 Participants
Number of Participants With Unsolicited Adverse Events. Rhinorrhoea	27 Participants	6 Participants
Number of Participants With Unsolicited Adverse Events. Sneezing	1 Participants	0 Participants

Adverse Events

GPO Tri Fluvac Vaccine

Serious events: 1 serious events

Other events: 273 other events

Deaths: 0 deaths

Licensed Influenza Vaccine

Serious events: 1 serious events

Other events: 114 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	GPO Tri Fluvac Vaccine n=630 participants at risk 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.	Licensed Influenza Vaccine n=315 participants at risk 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.
Musculoskeletal and connective tissue disorders FRACTURE	0.16% 1/630 • Number of events 1 • 90 days	0.00% 0/315 • 90 days
Cardiac disorders myocardial hypertrophy with infarction	0.00% 0/630 • 90 days	0.32% 1/315 • Number of events 1 • 90 days

Other adverse events

Other adverse events
Measure	GPO Tri Fluvac Vaccine n=630 participants at risk 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.	Licensed Influenza Vaccine n=315 participants at risk 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.
General disorders Pyrexia	3.8% 24/630 • Number of events 24 • 90 days	3.8% 12/315 • Number of events 13 • 90 days
Infections and infestations upper respiratory tract infection	17.6% 111/630 • Number of events 118 • 90 days	14.0% 44/315 • Number of events 47 • 90 days
Nervous system disorders headache	6.3% 40/630 • Number of events 44 • 90 days	5.1% 16/315 • Number of events 20 • 90 days
Respiratory, thoracic and mediastinal disorders rhinorrhoea	4.3% 27/630 • Number of events 28 • 90 days	1.9% 6/315 • Number of events 6 • 90 days
Gastrointestinal disorders adominal pain	0.16% 1/630 • Number of events 1 • 90 days	0.63% 2/315 • Number of events 2 • 90 days
Gastrointestinal disorders Diarrhoea	2.2% 14/630 • Number of events 14 • 90 days	1.3% 4/315 • Number of events 4 • 90 days
Gastrointestinal disorders Toothache	0.79% 5/630 • Number of events 5 • 90 days	0.95% 3/315 • Number of events 3 • 90 days
General disorders Influenza like illness	1.1% 7/630 • Number of events 7 • 90 days	0.95% 3/315 • Number of events 3 • 90 days
Infections and infestations pharyngitis	0.63% 4/630 • Number of events 4 • 90 days	0.32% 1/315 • Number of events 1 • 90 days
Injury, poisoning and procedural complications Contusion	0.48% 3/630 • Number of events 3 • 90 days	0.95% 3/315 • Number of events 3 • 90 days
Injury, poisoning and procedural complications skin abrasion	0.32% 2/630 • Number of events 2 • 90 days	0.95% 3/315 • Number of events 3 • 90 days
Musculoskeletal and connective tissue disorders myalgia	0.79% 5/630 • Number of events 5 • 90 days	0.95% 3/315 • Number of events 3 • 90 days
Reproductive system and breast disorders dysmenorrhoea	0.95% 6/630 • Number of events 8 • 90 days	1.6% 5/315 • Number of events 5 • 90 days
Respiratory, thoracic and mediastinal disorders cough	1.9% 12/630 • Number of events 13 • 90 days	1.3% 4/315 • Number of events 4 • 90 days
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	0.48% 3/630 • Number of events 3 • 90 days	0.63% 2/315 • Number of events 2 • 90 days
Respiratory, thoracic and mediastinal disorders rhinitis	0.79% 5/630 • Number of events 5 • 90 days	0.63% 2/315 • Number of events 2 • 90 days
Vascular disorders hypertension	0.63% 4/630 • Number of events 4 • 90 days	0.32% 1/315 • Number of events 1 • 90 days

Additional Information

Punnee Pitisuttithum

Mahidol

Phone: 6626435599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place