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
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).
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2007
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
First Submitted Date
Dec 19, 2007
First Submission Date that Met QC Criteria
Dec 21, 2007
First Posted Date
Dec 24, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 5, 2011
Results First Submitted that Met QC Criteria
Sep 5, 2011
Results First Posted Date
Oct 10, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 30, 2016
Last Update Posted Date
Jan 27, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NovartisINDUSTRY
Collaborators
Name
Class
Novartis Vaccines
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Randomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
One week postvaccination
Immunogenicity Assessment by Geometric Mean Titers (GMT).
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.
Three weeks postvaccination
Secondary Outcomes
Measure
Description
Time Frame
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
One week postvaccination
Number of Randomized Participants Reporting Local and Systemic Reactions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.
All subjects enrolled were included in the trial. The data entered is for overall study.
Recruitment Details
Study was conducted during the period of October 2007 to June 2008 at five sites in Poland.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
cTIV (Adults)
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).
egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
eTIV_a
cTIV or eTIV_a
Biological
0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.
FLU (cTIV or eTIV_a)
cTIV+PV OR eTIV_a+PV
Biological
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).
FLU (cTIV or eTIV_a) + PV
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.
One week postvaccination
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
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).
Three weeks postvaccination
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
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.
Three weeks postvaccination
Krakow
30-969
Poland
3
Krakow
31-115
Poland
2
Krakow
31-202
Poland
4
Krakow
31-832
Poland
FG001
eTIV_a (Adults)
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).
FG002
cTIV (Elderly)
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).
FG003
eTIV_a (Elderly)
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).
FG004
cTIV (Elderly; FLU Vaccination)
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.
FG005
cTIV+PV (Elderly; Concomitant Vaccination )
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).
FG006
eTIV_a (Elderly; FLU Vaccination)
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).
FG007
eTIV_a +PV (Elderly; Concomitant Vaccination)
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).
FG000549 subjects
FG001169 subjects
FG002391 subjects
FG003144 subjects
FG00490 subjects
FG00578 subjects
FG00657 subjects
FG00744 subjects
COMPLETED
FG000544 subjects
FG001168 subjects
FG002389 subjects
FG003143 subjects
FG00490 subjects
FG00578 subjects
FG00657 subjects
FG00742 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
cTIV (Adults)
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).
BG001
eTIV_a (Adults)
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).
BG002
cTIV (Elderly)
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).
BG003
eTIV_a (Elderly)
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).
BG004
cTIV (Elderly; FLU Vaccination)
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.
BG005
cTIV+PV (Elderly; Concomitant Vaccination )
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).
BG006
eTIV_a (Elderly; FLU Vaccination)
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).
BG007
eTIV_a +PV (Elderly; Concomitant Vaccination)
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).
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000549
BG001169
BG002391
BG003144
BG00490
BG00578
BG00657
BG00744
BG0081522
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Unrandomized adults
Title
Measurements
BG00044± 12.3
BG00143.3± 12.4
BG002NA± NAThis category does not belong to unrandomized adults
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000318
BG001102
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
Safety set.
Posted
Number
Subjects
One week postvaccination
ID
Title
Description
OG000
cTIV (Adults)
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).
OG001
eTIV_a (Adults)
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).
OG002
cTIV (Elderly)
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).
OG003
eTIV_a (Elderly)
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).
Units
Counts
Participants
OG000550
OG001168
OG002391
OG003
Title
Denominators
Categories
Local Reactions
Title
Measurements
OG000185
OG00160
OG00298
OG003
Secondary
Number of Randomized Participants Reporting Local and Systemic Reactions.
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.
Safety Set
Posted
Number
Subjects
One week postvaccination
ID
Title
Description
OG000
FLU (cTIV or eTIV_a) + PV
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)).
OG001
FLU (cTIV or eTIV_a)
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)).
OG002
cTIV (Elderly; FLU Vaccination)
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.
Primary
Number of Randomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.
Posted
Number
Subjects
One week postvaccination
ID
Title
Description
OG000
cTIV Total (Elderly)
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)).
OG001
eTIV_a Total (Elderly)
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)).
Units
Counts
Participants
Secondary
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
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).
Per Protocol Set
Posted
Number
Subjects
Three weeks postvaccination
ID
Title
Description
OG000
cTIV (Adults)
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).
OG001
eTIV_a (Adults)
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).
Secondary
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
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.
Per Protocol
Posted
Geometric Mean
95% Confidence Interval
Ratio
Three weeks postvaccination
ID
Title
Description
OG000
cTIV (Adults)
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).
OG001
eTIV_a (Adults)
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).
Primary
Immunogenicity Assessment by Geometric Mean Titers (GMT).
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.
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)
Posted
Geometric Mean
95% Confidence Interval
Titers
Three weeks postvaccination
ID
Title
Description
OG000
FLU (cTIV or eTIV_a) + PV
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).
OG001
FLU (cTIV or eTIV_a)
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).
Time Frame
Throughout the entire study period (six months)
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
cTIV (Adults)
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).
17
550
219
550
EG001
eTIV_a (Adults)
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).
5
168
73
168
EG002
cTIV (Elderly)
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).
23
391
119
391
EG003
eTIV_a (Elderly)
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).
6
144
40
144
EG004
cTIV (Elderly; FLU Vaccination)
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.
3
83
25
83
EG005
cTIV+PV (Elderly; Concomitant Vaccination )
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).
5
84
48
84
EG006
eTIV_a (Elderly; FLU Vaccination)
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).
1
52
23
52
EG007
eTIV_a +PV (Elderly; Concomitant Vaccination)
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).
6
50
21
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG0030 affected144 at risk
EG0040 affected83 at risk
EG0050 affected84 at risk
EG0060 affected52 at risk
EG0070 affected50 at risk
Acute myocardial infraction
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0003 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0022 affected391 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Myocardial infraction
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0011 affected168 at risk
EG0021 affected391 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Inner ear disorder
Ear and labyrinth disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Goitre
Endocrine disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Cataract
Eye disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Glaucoma
Eye disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Iridocele
Eye disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Vitreous prolapse
Eye disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Erysipelas
Infections and infestations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0011 affected168 at risk
EG0020 affected391 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Drug toxicity
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Diagnostic procedure
Investigations
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Neurilemmoma Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Rectal Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Motor neurone disease
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0021 affected391 at risk
EG003
Cataract operation
Surgical and medical procedures
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0023 affected391 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Status asthmaticus
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Arteriosclerosis obliterans
Vascular disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0011 affected168 at risk
EG0020 affected391 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Cervix adenomatous polyp
Reproductive system and breast disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA version 10.1
Non-systematic Assessment
EG0002 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA version 10.1
Non-systematic Assessment
EG0001 affected550 at risk
EG0010 affected168 at risk
EG0020 affected391 at risk
EG003
Uterovaginal prolapse
Reproductive system and breast disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0011 affected168 at risk
EG0020 affected391 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 10.1
Non-systematic Assessment
EG0000 affected550 at risk
EG0011 affected168 at risk
EG0020 affected391 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chills
General disorders
MedDRA version 10.1
Systematic Assessment
EG00015 affected550 at risk
EG0015 affected168 at risk
EG0025 affected391 at risk
EG0034 affected144 at risk
EG0042 affected83 at risk
EG0053 affected84 at risk
EG0063 affected52 at risk
EG0073 affected50 at risk
Fatigue
General disorders
MedDRA version 10.1
Systematic Assessment
EG00035 affected550 at risk
EG00111 affected168 at risk
EG00223 affected391 at risk
EG003
Injection site erythema
General disorders
MedDRA version 10.1
Systematic Assessment
EG00050 affected550 at risk
EG00120 affected168 at risk
EG00236 affected391 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA version 10.1
Non-systematic Assessment
EG00012 affected550 at risk
EG0011 affected168 at risk
EG00214 affected391 at risk
EG003
Injection site induration
General disorders
MedDRA version 10.1
Systematic Assessment
EG00038 affected550 at risk
EG00114 affected168 at risk
EG00226 affected391 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG00018 affected550 at risk
EG0015 affected168 at risk
EG00216 affected391 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG00041 affected550 at risk
EG0018 affected168 at risk
EG00225 affected391 at risk
EG003
Headache
Nervous system disorders
MedDRA version 10.1
Systematic Assessment
EG00042 affected550 at risk
EG00119 affected168 at risk
EG00220 affected391 at risk
EG003
Injection site swelling
General disorders
MedDRA version 10.1
Systematic Assessment
EG00023 affected550 at risk
EG0017 affected168 at risk
EG00217 affected391 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 10.1
Non-systematic Assessment
EG00018 affected550 at risk
EG0018 affected168 at risk
EG00213 affected391 at risk
EG003
Injection site pain
General disorders
MedDRA version 10.1
Systematic Assessment
EG000158 affected550 at risk
EG00151 affected168 at risk
EG00264 affected391 at risk
EG003
Malaise
General disorders
MedDRA version 10.1
Systematic Assessment
EG00052 affected550 at risk
EG00116 affected168 at risk
EG00237 affected391 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D007252
Influenza Vaccines
Ancestor Terms
ID
Term
D014765
Viral Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
BG003
NA
± NA
This category does not belong to unrandomized adults
BG004NA± NAThis category does not belong to unrandomized adults
BG005NA± NAThis category does not belong to unrandomized adults
BG006NA± NAThis category does not belong to unrandomized adults
BG007NA± NAThis category does not belong to unrandomized adults
BG00843.9± 12.3
Unrandomized elderly
Title
Measurements
BG000NA± NAThis category does not belong to unrandomized elderly
BG001NA± NAThis category does not belong to unrandomized elderly
BG00271.5± 5.5
BG00372.4± 5.7
BG004NA± NAThis category does not belong to unrandomized elderly
BG005NA± NAThis category does not belong to unrandomized elderly
BG006NA± NAThis category does not belong to unrandomized elderly
BG007NA± NAThis category does not belong to unrandomized elderly
BG00871.7± 5.6
Randomized elderly
Title
Measurements
BG000NA± NAThis category does not belong to randomized elderly
BG001NA± NAThis category does not belong to randomized elderly
BG002NA± NAThis category does not belong to randomized elderly
BG003NA± NAThis category does not belong to randomized elderly
BG00471.6± 5.9
BG00571.5± 5.5
BG00671.2± 4.9
BG00771.1± 5.2
BG00871.4± 5.5
232
BG00390
BG00446
BG00540
BG00638
BG00725
BG008891
Male
BG000231
BG00167
BG002159
BG00354
BG00444
BG00538
BG00619
BG00719
BG008631
144
26
Erythema
Title
Measurements
OG00050
OG00120
OG00236
OG00310
Induration
Title
Measurements
OG00038
OG00114
OG00226
OG0033
Swelling
Title
Measurements
OG00023
OG0017
OG00217
OG0033
Ecchymosis
Title
Measurements
OG00012
OG0011
OG00214
OG0032
Pain
Title
Measurements
OG000158
OG00151
OG00264
OG00312
Systemic Reaction
Title
Measurements
OG00099
OG00128
OG00257
OG00325
Chills
Title
Measurements
OG00015
OG0015
OG0025
OG0034
Malaise
Title
Measurements
OG00052
OG00116
OG00237
OG00316
Myalgia
Title
Measurements
OG00040
OG0018
OG00225
OG0038
Arthralgia
Title
Measurements
OG00018
OG0015
OG00216
OG0036
Headache
Title
Measurements
OG00039
OG00118
OG00220
OG00311
Sweating
Title
Measurements
OG00018
OG0018
OG00213
OG0038
Fatigue
Title
Measurements
OG00035
OG00111
OG00223
OG00311
Fever (≥ 38°C)
Title
Measurements
OG0002
OG0012
OG0020
OG0030
Analgesic and Antipyretics used
Title
Measurements
OG00017
OG00111
OG0027
OG0036
Stay at Home Due to Vaccination Reaction
Title
Measurements
OG0005
OG0015
OG0026
OG0033
OG003
cTIV+PV (Elderly; Concomitant Vaccination )
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).
OG004
eTIV_a (Elderly; FLU Vaccination)
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).
OG005
eTIV_a+PV (Elderly; Concomitant Vaccination)
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).
Units
Counts
Participants
OG000134
OG001135
OG00283
OG00384
OG00452
OG00550
Title
Denominators
Categories
Local Reactions
Title
Measurements
OG00049
OG00140
OG00220
OG00332
OG00420
OG00517
Ecchymosis
Title
Measurements
OG0007
OG0018
OG0023
OG003
Erythema
Title
Measurements
OG00020
OG00123
OG00212
OG003
Induration
Title
Measurements
OG0009
OG00114
OG0029
OG003
Swelling
Title
Measurements
OG0006
OG00110
OG0026
OG003
Pain
Title
Measurements
OG00031
OG00119
OG00211
OG003
Systemic Reaction
Title
Measurements
OG00029
OG00119
OG00210
OG003
Chills
Title
Measurements
OG0006
OG0015
OG0022
OG003
Malaise
Title
Measurements
OG00019
OG0019
OG0026
OG003
Myalgia
Title
Measurements
OG0008
OG0019
OG0026
OG003
Arthralgia
Title
Measurements
OG00014
OG0019
OG0026
OG003
Headache
Title
Measurements
OG00012
OG0019
OG0024
OG003
Sweating
Title
Measurements
OG0006
OG0017
OG0024
OG003
Fatigue
Title
Measurements
OG00010
OG0017
OG0026
OG003
Fever (≥ 38°C)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Analgesic and Antipyretics used
Title
Measurements
OG0008
OG0018
OG0025
OG003
Stayed at Home Due to Vaccination Reaction
Title
Measurements
OG0002
OG0010
OG0020
OG003
OG000167
OG001102
Title
Denominators
Categories
Local Reactions
Title
Measurements
OG00052
OG00137
Erythema
Title
Measurements
OG00024
OG00119
Induration
Title
Measurements
OG00015
OG0018
Swelling
Title
Measurements
OG0009
OG0017
Ecchymosis
Title
Measurements
OG0006
OG0019
Pain
Title
Measurements
OG00034
OG00116
Systemic Reaction
Title
Measurements
OG00032
OG00116
Chills
Title
Measurements
OG0005
OG0016
Malaise
Title
Measurements
OG00020
OG0018
Myalgia
Title
Measurements
OG00014
OG0013
Arthralgia
Title
Measurements
OG00017
OG0016
Headache
Title
Measurements
OG00015
OG0016
Sweating
Title
Measurements
OG0009
OG0014
Fatigue
Title
Measurements
OG00016
OG0011
Fever (≥ 38°C)
Title
Measurements
OG0000
OG0010
Analgesic and Antipyretics used
Title
Measurements
OG00011
OG0015
Stayed at Home Due to Vaccination Reaction
Title
Measurements
OG0002
OG0010
OG002
cTIV Total (Elderly)
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)).
OG003
eTIV_a Total (Elderly)
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)).
Units
Counts
Participants
OG00095
OG00123
OG00289
OG00362
Title
Denominators
Categories
HI titer ≥1:40 (H1N1)
Title
Measurements
OG00094
OG00123
OG00285
OG00355
seroconversion (H1N1)
Title
Measurements
OG00057
OG00113
OG00262
OG003
HI titer ≥1:40 (H3N2)
Title
Measurements
OG00092
OG00122
OG00286
OG003
seroconversion (H3N2)
Title
Measurements
OG00040
OG0018
OG00232
OG003
HI titer ≥1:40 (B)
Title
Measurements
OG00057
OG00116
OG00256
OG003
seroconversion (B)
Title
Measurements
OG00039
OG0018
OG00223
OG003
OG002
cTIV Total (Elderly)
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)).
OG003
eTIV_a Total (Elderly)
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)).
Units
Counts
Participants
OG00095
OG00123
OG00289
OG00362
Title
Denominators
Categories
GMR (H1N1; A/Solomon Islands/3/2006)
Title
Measurements
OG0005.6(4.27 to 7.34)
OG0014.38(2.52 to 7.6)
OG0027.75(5.93 to 10)
OG0035.92(4.29 to 8.16)
GMR (H3N2; A/Wisconsin/67/2005)
Title
Measurements
OG0003.63(2.83 to 4.64)
OG0012.33(1.41 to 3.85)
OG0022.65(2.22 to 3.16)
OG003
GMR (B; B/Malaysia/2506/2004)
Title
Measurements
OG0004.48(3.43 to 5.84)
OG0012.33(1.35 to 3.99)
OG0022.51(1.96 to 3.21)
OG003
Units
Counts
Participants
OG00074
OG00177
Title
Denominators
Categories
GMT Day 22 (H1N1)
Title
Measurements
OG000138(104 to 182)
OG001198(151 to 259)
GMT Day 22 (H3N2)
Title
Measurements
OG000184(141 to 240)
OG001228(176 to 296)
GMT Day 22 (B)
Title
Measurements
OG00036(27 to 47)
OG00152(40 to 68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Ratio of GMTs
0.66
2-Sided
95
0.45
0.98
A/H1N1(Day22)
Yes
Non-Inferiority or Equivalence
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.
OG000
OG001
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.
Ratio of GMTs
0.81
2-Sided
95
0.55
1.19
A/H3N2 (Day 22)-criterion was met
Yes
Non-Inferiority or Equivalence
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.
OG000
OG001
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.
Ratio of GMTs
0.69
2-Sided
95
0.46
1.02
B (Day 22)
Yes
Non-Inferiority or Equivalence
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.