Trial Outcomes & Findings for Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age (NCT NCT02285998)
NCT ID: NCT02285998
Last Updated: 2017-10-27
Results Overview
rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9003 participants
Primary outcome timeframe
14 days post vaccination through and up to 32 weeks post vaccination
Results posted on
2017-10-27
Participant Flow
Excludes 40 subjects who received randomization numbers, but who either withdrew prior to vaccination (n=15) or for whom the vaccine received could not be verified (n=25; 12 assigned to Flublok quadrivalent and 13 assigned to IIV4).
Participant milestones
| Measure |
Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
4474
|
4489
|
|
Overall Study
COMPLETED
|
4228
|
4236
|
|
Overall Study
NOT COMPLETED
|
246
|
253
|
Reasons for withdrawal
| Measure |
Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
176
|
172
|
|
Overall Study
Withdrawal by Subject
|
53
|
61
|
|
Overall Study
Other Reasons
|
7
|
10
|
Baseline Characteristics
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Baseline characteristics by cohort
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4328 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4344 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
Total
n=8672 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-64 years
|
2569 participants
n=93 Participants
|
2617 participants
n=4 Participants
|
5186 participants
n=27 Participants
|
|
Age, Customized
65-74 years
|
1234 participants
n=93 Participants
|
1254 participants
n=4 Participants
|
2488 participants
n=27 Participants
|
|
Age, Customized
75 years and older
|
525 participants
n=93 Participants
|
473 participants
n=4 Participants
|
998 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2532 Participants
n=93 Participants
|
2537 Participants
n=4 Participants
|
5069 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1796 Participants
n=93 Participants
|
1807 Participants
n=4 Participants
|
3603 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 days post vaccination through and up to 32 weeks post vaccinationPopulation: The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.
rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4303 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4301 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With rtPCR-confirmed Influenza-Like Illness
|
96 participants
|
138 participants
|
SECONDARY outcome
Timeframe: 14 days post vaccination through and up to 32 weeks post vaccinationPopulation: The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.
Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines. Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms: Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4303 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4301 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Culture-confirmed Influenza-Like Illness
|
58 participants
|
101 participants
|
SECONDARY outcome
Timeframe: 14 days post vaccination through and up to 32 weeks post vaccinationPopulation: The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.
Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines. CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4303 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4301 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness
|
38 participants
|
64 participants
|
SECONDARY outcome
Timeframe: 14 days post vaccination through and up to 32 weeks post vaccinationPopulation: The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.
rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4303 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4301 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness
|
54 participants
|
83 participants
|
SECONDARY outcome
Timeframe: Days 0 through 28Population: The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.
Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=314 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=300 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Percentage of Participants With Seroconversion
A/California
|
44.9 percentage of participants
Interval 39.3 to 50.6
|
49.0 percentage of participants
Interval 43.2 to 54.8
|
|
Percentage of Participants With Seroconversion
A/Texas
|
54.5 percentage of participants
Interval 48.8 to 60.1
|
43.3 percentage of participants
Interval 37.6 to 49.1
|
|
Percentage of Participants With Seroconversion
B/Massachusetts
|
38.9 percentage of participants
Interval 33.4 to 44.5
|
38.3 percentage of participants
Interval 32.8 to 44.1
|
|
Percentage of Participants With Seroconversion
B/Brisbane
|
21.0 percentage of participants
Interval 16.6 to 25.9
|
34.3 percentage of participants
Interval 29.0 to 40.0
|
SECONDARY outcome
Timeframe: Days 0 through 7Population: Solicited local reactogenicity events include subjects who recorded any injection site reaction data.
Solicited events of injection site reactogenicity reported during Day 0-7.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4307 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4319 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Local Injection Site Reactogenicity
|
1621 participants
|
1745 participants
|
SECONDARY outcome
Timeframe: Days 0 through 28Population: The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.
Unsolicited adverse events reported in the 28 days following vaccine administration.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4328 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4344 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
1345 participants
|
1355 participants
|
SECONDARY outcome
Timeframe: Day 0 through and up to 32 weeks post vaccinationPopulation: The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.
Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination). A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4328 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4344 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
SAEs
|
145 participants
|
132 participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
MAEs
|
774 participants
|
785 participants
|
SECONDARY outcome
Timeframe: Days 0 through 28Population: The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.
GMT titers for all four antigens in a preselected subset of subjects.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=314 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=300 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Measure of Post-vaccination HAI GMTs
Day 0 - A/California
|
45 titer
Interval 38.0 to 52.0
|
49 titer
Interval 42.0 to 57.0
|
|
Measure of Post-vaccination HAI GMTs
Day 28 - A/California
|
194 titer
Interval 167.0 to 226.0
|
224 titer
Interval 197.0 to 255.0
|
|
Measure of Post-vaccination HAI GMTs
Day 0 - A/Texas
|
88 titer
Interval 74.0 to 104.0
|
100 titer
Interval 84.0 to 119.0
|
|
Measure of Post-vaccination HAI GMTs
Day 28 - A/Texas
|
530 titer
Interval 470.0 to 597.0
|
366 titer
Interval 325.0 to 412.0
|
|
Measure of Post-vaccination HAI GMTs
Day 0 - B/Massachusetts
|
17 titer
Interval 15.0 to 20.0
|
18 titer
Interval 16.0 to 21.0
|
|
Measure of Post-vaccination HAI GMTs
Day 28 - B/Massachusetts
|
56 titer
Interval 49.0 to 64.0
|
58 titer
Interval 51.0 to 66.0
|
|
Measure of Post-vaccination HAI GMTs
Day 0 - B/Brisbane
|
14 titer
Interval 12.0 to 15.0
|
15 titer
Interval 13.0 to 16.0
|
|
Measure of Post-vaccination HAI GMTs
Day 28 - B/Brisbane
|
30 titer
Interval 26.0 to 34.0
|
44 titer
Interval 39.0 to 50.0
|
SECONDARY outcome
Timeframe: Days 0 through 7Population: Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.
Solicited events of systemic reactogenicity reported during Day 0-7.
Outcome measures
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4306 Participants
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4318 Participants
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Number of Participants With Systemic Reactogenicity
|
1077 participants
|
1106 participants
|
Adverse Events
Flublok Quadrivalent Influenza Vaccine
Serious events: 145 serious events
Other events: 1122 other events
Deaths: 0 deaths
Inactivated Influenza Vaccine
Serious events: 132 serious events
Other events: 1206 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4328 participants at risk
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4344 participants at risk
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.14%
6/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.14%
6/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Bronchitis
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Diverticulitis
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Influenza
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Urinary tract infection
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Lung Infection
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Osteomyelitis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Abscess intestinal
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Device related infection
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Eye abscess
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Gangrene
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Otitis media
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Salmonellosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.14%
6/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
4/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Angina pectoris
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Angina unstable
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Coronary artery disease
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiac arrest
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiogenic shock
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
8/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.16%
7/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.09%
4/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
5/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.14%
6/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.07%
3/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Syncope
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.07%
3/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Convulsion
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Embolic stroke
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Loss of consciousness
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Myelomalacia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Sinus headache
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Thalamic infarction
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
4/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.09%
4/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal wall neoplasm
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer recurrent
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyoma
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Chest pain
|
0.16%
7/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.14%
6/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Death
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Non-cardiac chest pain
|
0.07%
3/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Asthenia
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Hernia obstructive
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Oedema peripheral
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Pain
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.12%
5/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.12%
5/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
3/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Arteriosclerosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Haemorrhage
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Vascular disorders
Thrombosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Drug detoxification
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Gastric bypass
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Hernia repair
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Intestinal resection
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Joint surgery
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Renal and urinary disorders
Renal failure acute
|
0.07%
3/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Renal and urinary disorders
Urinary retention
|
0.05%
2/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Renal and urinary disorders
Renal necrosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Investigations
International normalised ratio increased
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Investigations
Troponin increased
|
0.02%
1/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.00%
0/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.05%
2/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4328 • From time vaccination until the end of the influenza season (~6 months).
|
0.02%
1/4344 • From time vaccination until the end of the influenza season (~6 months).
|
Other adverse events
| Measure |
Flublok Quadrivalent Influenza Vaccine
n=4328 participants at risk
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
|
Inactivated Influenza Vaccine
n=4344 participants at risk
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine: Intramuscular injection of vaccine
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
226/4328 • From time vaccination until the end of the influenza season (~6 months).
|
5.8%
253/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Influenza like illness
|
4.3%
186/4328 • From time vaccination until the end of the influenza season (~6 months).
|
4.6%
199/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
178/4328 • From time vaccination until the end of the influenza season (~6 months).
|
4.1%
177/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Nervous system disorders
Headache
|
3.3%
143/4328 • From time vaccination until the end of the influenza season (~6 months).
|
3.3%
145/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
129/4328 • From time vaccination until the end of the influenza season (~6 months).
|
3.6%
156/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
General disorders
Fatigue
|
2.4%
106/4328 • From time vaccination until the end of the influenza season (~6 months).
|
2.3%
100/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
95/4328 • From time vaccination until the end of the influenza season (~6 months).
|
1.8%
79/4344 • From time vaccination until the end of the influenza season (~6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
59/4328 • From time vaccination until the end of the influenza season (~6 months).
|
2.2%
97/4344 • From time vaccination until the end of the influenza season (~6 months).
|
Additional Information
Lisa M. Dunkle, M.D., Chief Medical Officer
Protein Sciences Corporation
Phone: 203-599-6064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place