Trial Outcomes & Findings for Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China (NCT NCT02228980)
NCT ID: NCT02228980
Last Updated: 2016-01-29
Results Overview
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
602 participants
Primary outcome timeframe
Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Results posted on
2016-01-29
Participant Flow
The study participants were enrolled from 05 September 2014 to 09 October 2014 at 1 clinical center at the Province of Guangxi China.
A total of 602 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participant milestones
| Measure |
Age 6 to 35 Months Group
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 18 to 60 Years Group
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
151
|
151
|
|
Overall Study
COMPLETED
|
126
|
147
|
149
|
148
|
|
Overall Study
NOT COMPLETED
|
24
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Age 6 to 35 Months Group
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 18 to 60 Years Group
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
7
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
3
|
Baseline Characteristics
Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China
Baseline characteristics by cohort
| Measure |
Age 6 to 35 Months Group
n=150 Participants
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
n=150 Participants
Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 18 to 60 Years Group
n=151 Participants
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
n=151 Participants
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
192 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Age, Continuous
|
1.45 Years
STANDARD_DEVIATION 0.597 • n=5 Participants
|
8.55 Years
STANDARD_DEVIATION 3.09 • n=7 Participants
|
46.5 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
69.8 Years
STANDARD_DEVIATION 6.37 • n=4 Participants
|
31.5 Years
STANDARD_DEVIATION 5.31425 • n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
331 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
602 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccinationPopulation: Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.
Outcome measures
| Measure |
Age 6 to 35 Months Group
n=150 Participants
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
n=150 Participants
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 8 to 60 Years Group
n=151 Participants
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
n=151 Participants
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H1N1 (Pre-dose; N=150,150,151,151)
|
12.8 Titers (1/dilution)
Interval 10.5 to 15.6
|
24.3 Titers (1/dilution)
Interval 20.1 to 29.4
|
11.2 Titers (1/dilution)
Interval 9.49 to 13.1
|
9 Titers (1/dilution)
Interval 7.68 to 10.5
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H1N1 (Post-dose; N=125,145,149,145)
|
152.2 Titers (1/dilution)
Interval 120.0 to 193.0
|
300.7 Titers (1/dilution)
Interval 243.0 to 372.0
|
188.3 Titers (1/dilution)
Interval 158.0 to 224.0
|
144 Titers (1/dilution)
Interval 116.0 to 180.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H3N2 (Pre-dose; n=150,150,151,151)
|
14.3 Titers (1/dilution)
Interval 11.3 to 18.1
|
62 Titers (1/dilution)
Interval 51.5 to 74.8
|
12.2 Titers (1/dilution)
Interval 10.4 to 14.4
|
21.1 Titers (1/dilution)
Interval 16.9 to 26.5
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H3N2 (Post-dose; N=125,146,149,147)
|
235.9 Titers (1/dilution)
Interval 191.0 to 291.0
|
236.2 Titers (1/dilution)
Interval 207.0 to 270.0
|
166.1 Titers (1/dilution)
Interval 140.0 to 197.0
|
237.8 Titers (1/dilution)
Interval 198.0 to 285.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
B (Pre-dose; N=150,150,151,151)
|
5.9 Titers (1/dilution)
Interval 5.49 to 6.3
|
17.7 Titers (1/dilution)
Interval 15.0 to 20.9
|
16.3 Titers (1/dilution)
Interval 13.7 to 19.5
|
15.3 Titers (1/dilution)
Interval 12.8 to 18.2
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
B (Post-dose; N=123,146,149,148)
|
108.5 Titers (1/dilution)
Interval 90.9 to 129.0
|
216.8 Titers (1/dilution)
Interval 180.0 to 261.0
|
202.8 Titers (1/dilution)
Interval 168.0 to 245.0
|
170 Titers (1/dilution)
Interval 140.0 to 207.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccinationPopulation: Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.
Outcome measures
| Measure |
Age 6 to 35 Months Group
n=150 Participants
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
n=150 Participants
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 8 to 60 Years Group
n=151 Participants
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
n=151 Participants
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
B (Pre-dose; N=150,150,151,151)
|
1.3 Percentage of participants
|
30.0 Percentage of participants
|
29.8 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H1N1 (Pre-dose; N=150,150,151,151)
|
31.3 Percentage of participants
|
45.3 Percentage of participants
|
17.2 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H1N1 (Post-dose; N=125,145,149,145)
|
88.8 Percentage of participants
|
94.5 Percentage of participants
|
96.6 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H3N2 (Pre-dose; N=150,150,151,151)
|
32.0 Percentage of participants
|
78.0 Percentage of participants
|
21.9 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H3N2 (Post-dose; N=125,146,149,147)
|
98.4 Percentage of participants
|
99.3 Percentage of participants
|
95.3 Percentage of participants
|
95.9 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
B (Post-dose; N=123,146,149,148)
|
93.5 Percentage of participants
|
95.2 Percentage of participants
|
98.7 Percentage of participants
|
93.9 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccinationPopulation: Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.
Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.
Outcome measures
| Measure |
Age 6 to 35 Months Group
n=125 Participants
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
n=146 Participants
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 8 to 60 Years Group
n=149 Participants
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
n=148 Participants
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H1N1 (N=125,145,149,145)
|
86.4 Percentage of participants
|
79.3 Percentage of participants
|
91.3 Percentage of participants
|
84.1 Percentage of participants
|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine
A/H3N2 (N=125,146,149,147)
|
90.4 Percentage of participants
|
56.2 Percentage of participants
|
83.2 Percentage of participants
|
78.2 Percentage of participants
|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine
B (N=123,146,149,148)
|
93.5 Percentage of participants
|
82.2 Percentage of participants
|
85.9 Percentage of participants
|
80.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 7 post any vaccinationPopulation: Solicited injection site and systemic reactions were assessed in the Safety Population.
Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years). Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever \>39.5˚C; Crying abnormal - \>3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)
Outcome measures
| Measure |
Age 6 to 35 Months Group
n=150 Participants
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Age 3 to 17 Years Group
n=150 Participants
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age 8 to 60 Years Group
n=151 Participants
Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Age ≥61 Years Group
n=151 Participants
Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Myalgia (N=70,148,150,151)
|
4 Participants
|
16 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Appetite lost (N=69,0,0,0)
|
20 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Injection site Tenderness/Pain (N=140,148,150,151)
|
38 Participants
|
52 Participants
|
25 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Tenderness/Pain (N=140,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Injection site Erythema (N=140,148,150,151)
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Inj. site Erythema (N=140,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Injection-site Swelling (n=140,148,150,151)
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Inj. site Swelling (n=140,148,150,151)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Injection site Induration (N=140,148,150,151)
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Inj. site Induration (N=140,148,150,151)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Injection site Ecchymosis (N=140,148,150,151)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Inj. site Ecchymosis (N=140,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Fever (N=138,148,149,150)
|
38 Participants
|
22 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Fever (N=138,148,149,150)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Headache (N=70,148,150,151)
|
1 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Headache (N=70,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Malaise (N=70,148,150,151)
|
5 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Malaise (N=70,148,150,151)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Myalgia (N=70,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Shivering (N=70,148,150,151)
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Shivering (N=70,148,150,151)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Crying abnormal (N=69,0,0,0)
|
20 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Crying abnormal (N=69,0,0,0)
|
0 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Drowsiness (N=69,0,0,0)
|
12 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Drowsiness (N=69,0,0,0)
|
1 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Appetite lost (N=69,0,0,0)
|
4 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Irritability (N=69,0,0,0)
|
14 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Irritability (N=69,0,0,0)
|
0 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Vomiting (N=69,0,0,0)
|
9 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Grade 3 Vomiting (N =69,0,0,0)
|
0 Participants
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
NA Participants
Event was not solicited in this group
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 4
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=150 participants at risk
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Group 2
n=150 participants at risk
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Group 3
n=151 participants at risk
Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Group 4
n=151 participants at risk
Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Infections and infestations
Hand foot and mouth disease
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Infections and infestations
Lung infection
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.66%
1/151 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.66%
1/151 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
Other adverse events
| Measure |
Group 1
n=150 participants at risk
Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
|
Group 2
n=150 participants at risk
Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Group 3
n=151 participants at risk
Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
Group 4
n=151 participants at risk
Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
21/150 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
2.0%
3/150 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
13/150 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
1.3%
2/150 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.66%
1/151 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.3%
11/150 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
General disorders
Injection site Pain/Tenderness
|
27.1%
38/140 • Number of events 38 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
35.1%
52/148 • Number of events 52 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
16.7%
25/150 • Number of events 25 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
7.9%
12/151 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
General disorders
Fever
|
27.5%
38/138 • Number of events 38 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
14.9%
22/148 • Number of events 22 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
4.0%
6/149 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
3.3%
5/150 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
5.4%
8/148 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
4.0%
6/150 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
2.6%
4/151 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
General disorders
Malaise
|
7.1%
5/70 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
7.4%
11/148 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
4.0%
6/150 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
3.3%
5/151 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
4/70 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
10.8%
16/148 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
3.3%
5/150 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.66%
1/151 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Psychiatric disorders
Crying abnormal
|
29.0%
20/69 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Nervous system disorders
Drowsiness
|
17.4%
12/69 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Metabolism and nutrition disorders
Appetite lost
|
29.0%
20/69 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Psychiatric disorders
Irritability
|
20.3%
14/69 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
9/69 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
—
0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
10/150 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
|
General disorders
Pyrexia
|
6.0%
9/150 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/150 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.
|
0.00%
0/151 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 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