Trial Outcomes & Findings for Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years (NCT NCT02550197)
NCT ID: NCT02550197
Last Updated: 2022-03-28
Results Overview
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 21 post-vaccination
Results posted on
2022-03-28
Participant Flow
The study participants were enrolled from 11 September 2015 to 03 November 2015 at 5 clinic sites in the Republic of Korea.
A total of 300 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Quadrivalent Influenza Vaccine Group
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
COMPLETED
|
200
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
Baseline characteristics by cohort
| Measure |
Quadrivalent Influenza Vaccine Group
n=200 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
35.9 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
35.6 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
35.8 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
200 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=199 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 0 (N=199, 100)
|
186 Titers (1/dilution)
Interval 156.0 to 220.0
|
139 Titers (1/dilution)
Interval 107.0 to 180.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 0 (N=199, 99)
|
142 Titers (1/dilution)
Interval 116.0 to 174.0
|
116 Titers (1/dilution)
Interval 86.1 to 155.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 21 (N=199, 99)
|
583 Titers (1/dilution)
Interval 516.0 to 658.0
|
651 Titers (1/dilution)
Interval 550.0 to 771.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 0 (N=199, 99)
|
41.6 Titers (1/dilution)
Interval 34.1 to 50.9
|
35.8 Titers (1/dilution)
Interval 27.2 to 47.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 21 (N=199, 99)
|
483 Titers (1/dilution)
Interval 406.0 to 574.0
|
691 Titers (1/dilution)
Interval 543.0 to 881.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 0 (N=199, 99)
|
256 Titers (1/dilution)
Interval 212.0 to 309.0
|
219 Titers (1/dilution)
Interval 166.0 to 290.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 21 (N=199, 99)
|
1068 Titers (1/dilution)
Interval 950.0 to 1200.0
|
1105 Titers (1/dilution)
Interval 933.0 to 1308.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 21 (N=199, 100)
|
737 Titers (1/dilution)
Interval 651.0 to 835.0
|
290 Titers (1/dilution)
Interval 231.0 to 364.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Seroprotection was assessed in the Immunogenicity Analysis Set.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=199 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 0 (N=199, 99)
|
83.4 Percentage of Participants
|
78.8 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 21 (N=199, 99)
|
99.5 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 0 (N=199, 99)
|
56.3 Percentage of Participants
|
55.6 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 21 (N=199, 99)
|
98.0 Percentage of Participants
|
99.0 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 0 (N=199, 99)
|
91.5 Percentage of Participants
|
87.9 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 21 (N=199, 99)
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 0 (N=199, 100)
|
89.4 Percentage of Participants
|
85.0 Percentage of Participants
|
|
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 21 (N=199, 100)
|
100.0 Percentage of Participants
|
97.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Immunogenicity was assessed in the Immunogenicity Analysis Set.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=199 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 0 (N=199, 100)
|
0.5 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 0 (N=199, 99)
|
5.5 Percentage of Participants
|
6.1 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1; Day 21 (N=199, 99)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 0 (N=199, 99)
|
17.1 Percentage of Participants
|
20.2 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2; Day 21 (N=199, 99)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 0 (N=199, 99)
|
1.5 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket; Day 21 (N=199, 99)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris; Day 21 (N=199, 100)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 21 post-vaccinationPopulation: Immunogenicity was assessed in the Immunogenicity Analysis Set.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=199 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1 (N=199, 99)
|
39.7 Percentage of Participants
|
46.5 Percentage of Participants
|
|
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2 (N=199, 99)
|
72.4 Percentage of Participants
|
84.8 Percentage of Participants
|
|
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket (N=199, 99)
|
48.7 Percentage of Participants
|
53.5 Percentage of Participants
|
|
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris (N=199, 100)
|
46.2 Percentage of Participants
|
23.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=199 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Bris (N=199, 100)
|
3.97 Titer ratio
Interval 3.3 to 4.78
|
2.08 Titer ratio
Interval 1.75 to 2.48
|
|
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H1N1 (N=199, 99)
|
4.10 Titer ratio
Interval 3.3 to 5.09
|
5.64 Titer ratio
Interval 4.09 to 7.76
|
|
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
A/H3N2 (N=199, 99)
|
11.6 Titer ratio
Interval 9.16 to 14.7
|
19.3 Titer ratio
Interval 13.9 to 26.8
|
|
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
B/Phuket (N=199, 99)
|
4.17 Titer ratio
Interval 3.49 to 4.98
|
5.04 Titer ratio
Interval 3.81 to 6.67
|
PRIMARY outcome
Timeframe: Day 0 up Day 3 post-vaccinationPopulation: Solicited reactions were analyzed in the Safety Analysis Set.
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature \>38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=200 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Reaction listed in the EMA note for guidance
|
34.5 Percentage of Participants
|
40.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Injection site Induration (≥50 mm for 4 days)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Injection site Ecchymosis (Inj. site Bruising)
|
6.0 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Pyrexia (temperature >38.0˚C for at least 1 day)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Malaise
|
31.0 Percentage of Participants
|
40.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Shivering (Rigors)
|
5.5 Percentage of Participants
|
6.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 up Day 7 post-vaccinationPopulation: Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group
n=200 Participants
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 Participants
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Shivering
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Injection-site Pain
|
70.5 Percentage of Participants
|
64.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Injection-site Pain
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Injection-site Erythema
|
2.5 Percentage of Participants
|
3.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Injection-site Erythema
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Injection-site Swelling
|
3.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Injection-site Swelling
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Injection-site Induration
|
3.0 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Injection-site Induration
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Injection-site Ecchymosis
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Injection-site Ecchymosis
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Fever
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Fever
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Headache
|
16.5 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Headache
|
1.5 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Malaise
|
33.5 Percentage of Participants
|
42.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Malaise
|
1.5 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Myalgia
|
51.0 Percentage of Participants
|
49.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Grade 3 Myalgia
|
1.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Any Shivering
|
6.5 Percentage of Participants
|
6.0 Percentage of Participants
|
Adverse Events
Quadrivalent Influenza Vaccine Group
Serious events: 0 serious events
Other events: 141 other events
Deaths: 0 deaths
Trivalent Influenza Vaccine Group
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quadrivalent Influenza Vaccine Group
n=200 participants at risk
Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
|
Trivalent Influenza Vaccine Group
n=100 participants at risk
Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
|
|---|---|---|
|
General disorders
Injection site Pain
|
70.5%
141/200 • Number of events 141 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
64.0%
64/100 • Number of events 64 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
|
Nervous system disorders
Headache
|
16.5%
33/200 • Number of events 33 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
20.0%
20/100 • Number of events 20 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
|
General disorders
Malaise
|
33.5%
67/200 • Number of events 67 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
42.0%
42/100 • Number of events 42 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
51.0%
102/200 • Number of events 102 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
49.0%
49/100 • Number of events 49 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
|
General disorders
Shivering
|
6.5%
13/200 • Number of events 13 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
6.0%
6/100 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER