Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00579345
Collaborator
Novartis Vaccines (Industry)
1,522
5
4
8
304.4
38
Study Details
Study Description
Brief Summary
The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1522 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Phase III, Single-Blind, Multi-Center, Extension Study to Evaluate Safety and Tolerability of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adult and Elderly Subjects Who Participated in Study V58P4, With Subset Analyses of Immunogenicity and Evaluation of Concomitant Polysaccharide Pneumococcal Vaccine (Elderly).
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cTIV Cell culture derived seasonal trivalent influenza vaccine (cTIV) |
Biological: Cell culture derived seasonal trivalent influenza vaccine (cTIV)
cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
|
| Active Comparator: eTIV_a Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) |
Biological: Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
|
| Experimental: FLU (cTIV or eTIV_a) Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a). |
Biological: cTIV or eTIV_a
0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.
|
| Active Comparator: FLU (cTIV or eTIV_a) + PV 23-valent Pneumococcal vaccine (PV) concomitantly administered with cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a). |
Biological: cTIV+PV OR eTIV_a+PV
0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).
|
Outcome Measures
Primary Outcome Measures
- Number of Randomized Participants Reporting Local and Systemic Reactions. [One week postvaccination]
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
- Immunogenicity Assessment by Geometric Mean Titers (GMT). [Three weeks postvaccination]
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
Secondary Outcome Measures
- Number of Unrandomized Participants Reporting Local and Systemic Reactions. [One week postvaccination]
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
- Number of Randomized Participants Reporting Local and Systemic Reactions. [One week postvaccination]
Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.
- Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. [Three weeks postvaccination]
Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96). Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10).
- Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. [Three weeks postvaccination]
Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
participation in the V58P4 study
-
mentally competent to understand the nature, the scope and the consequences of the study
-
able and willing to give written informed consent prior to study entry
-
available for all the visits scheduled in the study
Exclusion Criteria:
-
receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study
-
history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components
-
any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit 7
-
pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 5 | Krakow | Poland | 25-381 | |
| 2 | 1 | Krakow | Poland | 30-969 | |
| 3 | 3 | Krakow | Poland | 31-115 | |
| 4 | 2 | Krakow | Poland | 31-202 | |
| 5 | 4 | Krakow | Poland | 31-832 |
Sponsors and Collaborators
- Novartis
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00579345
Other Study ID Numbers:
- V58P4E2
- 2006-003077-27
First Posted:
Dec 24, 2007
Last Update Posted:
Jan 27, 2017
Last Verified:
Oct 1, 2012
Study Results
Participant Flow
| Recruitment Details | Study was conducted during the period of October 2007 to June 2008 at five sites in Poland. |
|---|---|
| Pre-assignment Detail | All subjects enrolled were included in the trial. The data entered is for overall study. |
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study. | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). |
| Period Title: Overall Study | ||||||||
| STARTED | 549 | 169 | 391 | 144 | 90 | 78 | 57 | 44 |
| COMPLETED | 544 | 168 | 389 | 143 | 90 | 78 | 57 | 42 |
| NOT COMPLETED | 5 | 1 | 2 | 1 | 0 | 0 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study. | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Total of all reporting groups |
| Overall Participants | 549 | 169 | 391 | 144 | 90 | 78 | 57 | 44 | 1522 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Unrandomized adults |
44
(12.3)
|
43.3
(12.4)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
43.9
(12.3)
|
| Unrandomized elderly |
NA
(NA)
|
NA
(NA)
|
71.5
(5.5)
|
72.4
(5.7)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
71.7
(5.6)
|
| Randomized elderly |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
71.6
(5.9)
|
71.5
(5.5)
|
71.2
(4.9)
|
71.1
(5.2)
|
71.4
(5.5)
|
| Gender (Count of Participants) | |||||||||
| Female |
318
57.9%
|
102
60.4%
|
232
59.3%
|
90
62.5%
|
46
51.1%
|
40
51.3%
|
38
66.7%
|
25
56.8%
|
891
58.5%
|
| Male |
231
42.1%
|
67
39.6%
|
159
40.7%
|
54
37.5%
|
44
48.9%
|
38
48.7%
|
19
33.3%
|
19
43.2%
|
631
41.5%
|
Outcome Measures
| Title | Number of Unrandomized Participants Reporting Local and Systemic Reactions. |
|---|---|
| Description | Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. |
| Time Frame | One week postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set. |
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) |
|---|---|---|---|---|
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). |
| Measure Participants | 550 | 168 | 391 | 144 |
| Local Reactions |
185
|
60
|
98
|
26
|
| Erythema |
50
|
20
|
36
|
10
|
| Induration |
38
|
14
|
26
|
3
|
| Swelling |
23
|
7
|
17
|
3
|
| Ecchymosis |
12
|
1
|
14
|
2
|
| Pain |
158
|
51
|
64
|
12
|
| Systemic Reaction |
99
|
28
|
57
|
25
|
| Chills |
15
|
5
|
5
|
4
|
| Malaise |
52
|
16
|
37
|
16
|
| Myalgia |
40
|
8
|
25
|
8
|
| Arthralgia |
18
|
5
|
16
|
6
|
| Headache |
39
|
18
|
20
|
11
|
| Sweating |
18
|
8
|
13
|
8
|
| Fatigue |
35
|
11
|
23
|
11
|
| Fever (≥ 38°C) |
2
|
2
|
0
|
0
|
| Analgesic and Antipyretics used |
17
|
11
|
7
|
6
|
| Stay at Home Due to Vaccination Reaction |
5
|
5
|
6
|
3
|
| Title | Number of Randomized Participants Reporting Local and Systemic Reactions. |
|---|---|
| Description | Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site. |
| Time Frame | One week postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set |
| Arm/Group Title | FLU (cTIV or eTIV_a) + PV | FLU (cTIV or eTIV_a) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a+PV (Elderly; Concomitant Vaccination) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)). | Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study. | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study). |
| Measure Participants | 134 | 135 | 83 | 84 | 52 | 50 |
| Local Reactions |
49
|
40
|
20
|
32
|
20
|
17
|
| Ecchymosis |
7
|
8
|
3
|
3
|
5
|
4
|
| Erythema |
20
|
23
|
12
|
12
|
11
|
8
|
| Induration |
9
|
14
|
9
|
6
|
5
|
3
|
| Swelling |
6
|
10
|
6
|
3
|
4
|
3
|
| Pain |
31
|
19
|
11
|
23
|
8
|
8
|
| Systemic Reaction |
29
|
19
|
10
|
22
|
9
|
7
|
| Chills |
6
|
5
|
2
|
3
|
3
|
3
|
| Malaise |
19
|
9
|
6
|
14
|
3
|
5
|
| Myalgia |
8
|
9
|
6
|
8
|
3
|
0
|
| Arthralgia |
14
|
9
|
6
|
11
|
3
|
3
|
| Headache |
12
|
9
|
4
|
11
|
5
|
1
|
| Sweating |
6
|
7
|
4
|
5
|
3
|
1
|
| Fatigue |
10
|
7
|
6
|
10
|
1
|
0
|
| Fever (≥ 38°C) |
0
|
0
|
0
|
0
|
0
|
0
|
| Analgesic and Antipyretics used |
8
|
8
|
5
|
6
|
3
|
2
|
| Stayed at Home Due to Vaccination Reaction |
2
|
0
|
0
|
2
|
0
|
0
|
| Title | Number of Randomized Participants Reporting Local and Systemic Reactions. |
|---|---|
| Description | Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site. |
| Time Frame | One week postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data. |
| Arm/Group Title | cTIV Total (Elderly) | eTIV_a Total (Elderly) |
|---|---|---|
| Arm/Group Description | Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). | Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). |
| Measure Participants | 167 | 102 |
| Local Reactions |
52
|
37
|
| Erythema |
24
|
19
|
| Induration |
15
|
8
|
| Swelling |
9
|
7
|
| Ecchymosis |
6
|
9
|
| Pain |
34
|
16
|
| Systemic Reaction |
32
|
16
|
| Chills |
5
|
6
|
| Malaise |
20
|
8
|
| Myalgia |
14
|
3
|
| Arthralgia |
17
|
6
|
| Headache |
15
|
6
|
| Sweating |
9
|
4
|
| Fatigue |
16
|
1
|
| Fever (≥ 38°C) |
0
|
0
|
| Analgesic and Antipyretics used |
11
|
5
|
| Stayed at Home Due to Vaccination Reaction |
2
|
0
|
| Title | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. |
|---|---|
| Description | Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96). Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10). |
| Time Frame | Three weeks postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set |
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV Total (Elderly) | eTIV_a Total (Elderly) |
|---|---|---|---|---|
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). | Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). |
| Measure Participants | 95 | 23 | 89 | 62 |
| HI titer ≥1:40 (H1N1) |
94
|
23
|
85
|
55
|
| seroconversion (H1N1) |
57
|
13
|
62
|
41
|
| HI titer ≥1:40 (H3N2) |
92
|
22
|
86
|
59
|
| seroconversion (H3N2) |
40
|
8
|
32
|
25
|
| HI titer ≥1:40 (B) |
57
|
16
|
56
|
33
|
| seroconversion (B) |
39
|
8
|
23
|
18
|
| Title | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. |
|---|---|
| Description | Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5. |
| Time Frame | Three weeks postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol |
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV Total (Elderly) | eTIV_a Total (Elderly) |
|---|---|---|---|---|
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). | Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)). |
| Measure Participants | 95 | 23 | 89 | 62 |
| GMR (H1N1; A/Solomon Islands/3/2006) |
5.6
|
4.38
|
7.75
|
5.92
|
| GMR (H3N2; A/Wisconsin/67/2005) |
3.63
|
2.33
|
2.65
|
2.89
|
| GMR (B; B/Malaysia/2506/2004) |
4.48
|
2.33
|
2.51
|
2.97
|
| Title | Immunogenicity Assessment by Geometric Mean Titers (GMT). |
|---|---|
| Description | Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5. |
| Time Frame | Three weeks postvaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline) |
| Arm/Group Title | FLU (cTIV or eTIV_a) + PV | FLU (cTIV or eTIV_a) |
|---|---|---|
| Arm/Group Description | Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV). | Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a). |
| Measure Participants | 74 | 77 |
| GMT Day 22 (H1N1) |
138
|
198
|
| GMT Day 22 (H3N2) |
184
|
228
|
| GMT Day 22 (B) |
36
|
52
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | cTIV (Adults), eTIV_a (Adults) |
|---|---|---|
| Comments | The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.66 | |
| Confidence Interval |
(2-Sided) 95% 0.45 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | A/H1N1(Day22) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | cTIV (Adults), eTIV_a (Adults) |
|---|---|---|
| Comments | The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.55 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | A/H3N2 (Day 22)-criterion was met | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | cTIV (Adults), eTIV_a (Adults) |
|---|---|---|
| Comments | The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.69 | |
| Confidence Interval |
(2-Sided) 95% 0.46 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | B (Day 22) | |
Adverse Events
| Time Frame | Throughout the entire study period (six months) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Other Adverse Events (AEs) (>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites. | |||||||||||||||
| Arm/Group Title | cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | ||||||||
| Arm/Group Description | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm). | Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study. | Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study). | ||||||||
All Cause Mortality |
||||||||||||||||
| cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/550 (3.1%) | 5/168 (3%) | 23/391 (5.9%) | 6/144 (4.2%) | 3/83 (3.6%) | 5/84 (6%) | 1/52 (1.9%) | 6/50 (12%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anaemia | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Acute myocardial infraction | 3/550 (0.5%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Angina pectoris | 1/550 (0.2%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Atrial fibrillation | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 1/83 (1.2%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Atrial flutter | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Atrioventricular block complete | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Cardiac arrest | 1/550 (0.2%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Cardiac failure | 0/550 (0%) | 0/168 (0%) | 2/391 (0.5%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Cardiac valve disease | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Myocardial infraction | 0/550 (0%) | 1/168 (0.6%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Myocardial ischaemia | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Sinus bradycardia | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Sinus tachycardia | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Tachycardia paroxysmal | 0/550 (0%) | 1/168 (0.6%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Hypoacusis | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Inner ear disorder | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Tinnitus | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Vertigo | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Endocrine disorders | ||||||||||||||||
| Goitre | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Cataract | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Glaucoma | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Iridocele | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Vitreous prolapse | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Colonic polyp | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Inguinal hernia | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 1/52 (1.9%) | 0/50 (0%) | ||||||||
| Rectal polyp | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Vomiting | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Cholelithiasis | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Erysipelas | 0/550 (0%) | 1/168 (0.6%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Gastroenteritis | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 1/83 (1.2%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Herpes zoster | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Pneumonia | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Pulmonary tuberculosis | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Drug toxicity | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Eye injury | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Joint dislocation | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Overdose | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Radius fracture | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Spinal compression fracture | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Diagnostic procedure | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Diabetes mellitus | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Foot deformity | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Lumbar spinal stenosis | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Osteoarthritis | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 1/83 (1.2%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Bladder cancer | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| lung neoplasm malignant | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Neurilemmoma Malignant | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Rectal Adenoma | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Uterine Leiomyoma | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Ischaemic Stroke | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Loss of consciousness | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Motor neurone disease | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Syncope | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Cerebrovascular accident | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Epilepsy | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Renal failure chronic | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Cervix adenomatous polyp | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Metrorrhagia | 2/550 (0.4%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Uterine polyp | 1/550 (0.2%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Uterovaginal prolapse | 0/550 (0%) | 1/168 (0.6%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Bronchitis chronic | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Respiratory failure | 0/550 (0%) | 0/168 (0%) | 1/391 (0.3%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Status asthmaticus | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Psoriasis | 0/550 (0%) | 1/168 (0.6%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Surgical and medical procedures | ||||||||||||||||
| Cataract operation | 1/550 (0.2%) | 0/168 (0%) | 3/391 (0.8%) | 0/144 (0%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 1/50 (2%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Circulatory collapse | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 1/144 (0.7%) | 0/83 (0%) | 0/84 (0%) | 0/52 (0%) | 0/50 (0%) | ||||||||
| Arteriosclerosis obliterans | 0/550 (0%) | 0/168 (0%) | 0/391 (0%) | 0/144 (0%) | 0/83 (0%) | 1/84 (1.2%) | 0/52 (0%) | 0/50 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 219/550 (39.8%) | 73/168 (43.5%) | 119/391 (30.4%) | 40/144 (27.8%) | 25/83 (30.1%) | 48/84 (57.1%) | 23/52 (44.2%) | 21/50 (42%) | ||||||||
| General disorders | ||||||||||||||||
| Chills | 15/550 (2.7%) | 5/168 (3%) | 5/391 (1.3%) | 4/144 (2.8%) | 2/83 (2.4%) | 3/84 (3.6%) | 3/52 (5.8%) | 3/50 (6%) | ||||||||
| Fatigue | 35/550 (6.4%) | 11/168 (6.5%) | 23/391 (5.9%) | 11/144 (7.6%) | 7/83 (8.4%) | 10/84 (11.9%) | 2/52 (3.8%) | 0/50 (0%) | ||||||||
| Injection site erythema | 50/550 (9.1%) | 20/168 (11.9%) | 36/391 (9.2%) | 10/144 (6.9%) | 12/83 (14.5%) | 19/84 (22.6%) | 11/52 (21.2%) | 8/50 (16%) | ||||||||
| Injection site haemorrhage | 12/550 (2.2%) | 1/168 (0.6%) | 14/391 (3.6%) | 2/144 (1.4%) | 3/83 (3.6%) | 5/84 (6%) | 5/52 (9.6%) | 5/50 (10%) | ||||||||
| Injection site induration | 38/550 (6.9%) | 14/168 (8.3%) | 26/391 (6.6%) | 3/144 (2.1%) | 9/83 (10.8%) | 11/84 (13.1%) | 5/52 (9.6%) | 5/50 (10%) | ||||||||
| Injection site swelling | 23/550 (4.2%) | 7/168 (4.2%) | 17/391 (4.3%) | 3/144 (2.1%) | 6/83 (7.2%) | 4/84 (4.8%) | 4/52 (7.7%) | 4/50 (8%) | ||||||||
| Injection site pain | 158/550 (28.7%) | 51/168 (30.4%) | 64/391 (16.4%) | 12/144 (8.3%) | 11/83 (13.3%) | 32/84 (38.1%) | 8/52 (15.4%) | 10/50 (20%) | ||||||||
| Malaise | 52/550 (9.5%) | 16/168 (9.5%) | 37/391 (9.5%) | 16/144 (11.1%) | 7/83 (8.4%) | 14/84 (16.7%) | 3/52 (5.8%) | 5/50 (10%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 18/550 (3.3%) | 5/168 (3%) | 16/391 (4.1%) | 6/144 (4.2%) | 7/83 (8.4%) | 11/84 (13.1%) | 3/52 (5.8%) | 3/50 (6%) | ||||||||
| Myalgia | 41/550 (7.5%) | 8/168 (4.8%) | 25/391 (6.4%) | 8/144 (5.6%) | 6/83 (7.2%) | 8/84 (9.5%) | 3/52 (5.8%) | 0/50 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Headache | 42/550 (7.6%) | 19/168 (11.3%) | 20/391 (5.1%) | 11/144 (7.6%) | 5/83 (6%) | 12/84 (14.3%) | 5/52 (9.6%) | 1/50 (2%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Hyperhidrosis | 18/550 (3.3%) | 8/168 (4.8%) | 13/391 (3.3%) | 8/144 (5.6%) | 5/83 (6%) | 5/84 (6%) | 3/52 (5.8%) | 1/50 (2%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00579345
Other Study ID Numbers:
- V58P4E2
- 2006-003077-27
First Posted:
Dec 24, 2007
Last Update Posted:
Jan 27, 2017
Last Verified:
Oct 1, 2012