Trial Outcomes & Findings for Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008 (NCT NCT00511914)
NCT ID: NCT00511914
Last Updated: 2013-01-24
Results Overview
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
3 weeks postvaccination (Day 22)
Results posted on
2013-01-24
Participant Flow
Participant milestones
| Measure |
cTIV (Adults)
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
COMPLETED
|
68
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008
Baseline characteristics by cohort
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
37.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Outcome measures
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H1N1 Prevaccination (Day 1)
|
22 Titer
Interval 14.0 to 33.0
|
23 Titer
Interval 17.0 to 31.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H1N1 Postvaccination (Day 22)
|
624 Titer
Interval 442.0 to 881.0
|
199 Titer
Interval 150.0 to 264.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H3N2 Prevaccination (Day 1)
|
36 Titer
Interval 24.0 to 56.0
|
80 Titer
Interval 53.0 to 122.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H3N2 Postvaccination (Day 22)
|
405 Titer
Interval 299.0 to 547.0
|
283 Titer
Interval 205.0 to 390.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
B Prevaccination (Day 1)
|
8.16 Titer
Interval 6.43 to 10.0
|
16 Titer
Interval 12.0 to 21.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
B Postvaccination (Day 22)
|
96 Titer
Interval 66.0 to 139.0
|
40 Titer
Interval 30.0 to 53.0
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Outcome measures
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
A/H1N1 (Day 22 / Day1)
|
29 Ratio
Interval 18.0 to 46.0
|
8.74 Ratio
Interval 6.13 to 12.0
|
|
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
A/H3N2 (Day 22 / Day1)
|
11 Ratio
Interval 7.27 to 17.0
|
3.53 Ratio
Interval 2.47 to 5.06
|
|
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
B (Day 22 / Day1)
|
12 Ratio
Interval 7.69 to 18.0
|
2.51 Ratio
Interval 1.93 to 3.27
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70% for adults and \>60% for elderly subjects.
Outcome measures
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H1N1 Prevaccination (Day 1)
|
35 Percentages of Subjects
Interval 24.0 to 48.0
|
37 Percentages of Subjects
Interval 26.0 to 50.0
|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H1N1 Postvaccination (Day 22)
|
96 Percentages of Subjects
Interval 88.0 to 99.0
|
96 Percentages of Subjects
Interval 87.0 to 99.0
|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H3N2 Prevaccination (Day 1)
|
51 Percentages of Subjects
Interval 39.0 to 64.0
|
72 Percentages of Subjects
Interval 59.0 to 82.0
|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H3N2 Postvaccination (Day 22)
|
97 Percentages of Subjects
Interval 90.0 to 100.0
|
96 Percentages of Subjects
Interval 87.0 to 99.0
|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
B Prevaccination (Day 1)
|
13 Percentages of Subjects
Interval 6.0 to 24.0
|
28 Percentages of Subjects
Interval 18.0 to 41.0
|
|
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
B Postvaccination (Day 22)
|
79 Percentages of Subjects
Interval 68.0 to 88.0
|
66 Percentages of Subjects
Interval 53.0 to 77.0
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Proportion of subjects with either seroconversion (antibody increase from \< 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination). According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be \>40% for adults and \>30% for elderly subjects.
Outcome measures
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H1N1
|
79 Percentages of Subjects
Interval 68.0 to 88.0
|
67 Percentages of Subjects
Interval 55.0 to 78.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
A/H3N2
|
72 Percentages of Subjects
Interval 60.0 to 82.0
|
40 Percentages of Subjects
Interval 28.0 to 53.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
B
|
65 Percentages of Subjects
Interval 52.0 to 76.0
|
25 Percentages of Subjects
Interval 16.0 to 37.0
|
SECONDARY outcome
Timeframe: 3 days postvaccinationPopulation: Analysis was done on safety set.
To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.
Outcome measures
| Measure |
cTIV (Adults)
n=68 Participants
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 Participants
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
Number of Subjects Reporting Local and Systemic Reactions
Redness/Erythema
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Swelling
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Pain
|
31 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Ecchymosis
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Induration
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Fever ( ≥ 38°C)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Malaise
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Fatigue
|
10 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Headache
|
12 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Sweating
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Myalgia
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Arthralgia
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Chills
|
0 Subjects
|
0 Subjects
|
Adverse Events
cTIV (Adults)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
cTIV (Elderly)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
cTIV (Adults)
n=68 participants at risk
Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
cTIV (Elderly)
n=67 participants at risk
Elderly subjects \>= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
|
|---|---|---|
|
General disorders
Fatigue
|
14.7%
10/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
11.9%
8/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
|
General disorders
Injection site induration
|
7.4%
5/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
7.5%
5/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
|
General disorders
Injection site pain
|
45.6%
31/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
23.9%
16/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
|
General disorders
Malaise
|
7.4%
5/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
4.5%
3/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
4/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
4.5%
3/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
|
Nervous system disorders
Headache
|
17.6%
12/68 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
13.4%
9/67 • All solicited adverse reactions were collected from Day 0 - Day 3. All unsolicited adverse events and Serious adverse events were collected throughout study period (Day 0- Day 21).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60