Trial Outcomes & Findings for Study of Quadrivalent Influenza Vaccine Among Adults (NCT NCT01218646)

Last Updated: 2013-10-23

Results Overview

Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

739 participants

Primary outcome timeframe

Day 21 post-vaccination

Results posted on

2013-10-23

Participant Flow

The study participants were enrolled from 08 October through 01 December 2010 in 12 clinic centers in the US.

A total of 739 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.

Participant milestones

Participant milestones
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
Overall Study STARTED	225	225	225	64
Overall Study COMPLETED	224	225	223	63
Overall Study NOT COMPLETED	1	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Protocol Violation	0	1	1

Baseline Characteristics

Study of Quadrivalent Influenza Vaccine Among Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=64 Participants Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Total n=739 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	64 Participants n=4 Participants	64 Participants n=21 Participants
Age, Categorical >=65 years	225 Participants n=5 Participants	225 Participants n=7 Participants	225 Participants n=5 Participants	0 Participants n=4 Participants	675 Participants n=21 Participants
Age Continuous	72.4 Years STANDARD_DEVIATION 5.7 • n=5 Participants	72.8 Years STANDARD_DEVIATION 5.6 • n=7 Participants	72.8 Years STANDARD_DEVIATION 5.3 • n=5 Participants	46.0 Years STANDARD_DEVIATION 11.6 • n=4 Participants	70.4 Years STANDARD_DEVIATION 9.8 • n=21 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	121 Participants n=7 Participants	126 Participants n=5 Participants	27 Participants n=4 Participants	403 Participants n=21 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	104 Participants n=7 Participants	99 Participants n=5 Participants	37 Participants n=4 Participants	336 Participants n=21 Participants
Region of Enrollment United States	225 Participants n=5 Participants	225 Participants n=7 Participants	225 Participants n=5 Participants	64 Participants n=4 Participants	739 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 21 post-vaccination

Population: Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (\<LLOQ or \>ULOQ).

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. B/Brisbane/60/2008 (220, 0, 219, 0)	73.8 Titers Interval 63.9 to 85.3	NA Titers B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group	57.9 Titers Interval 50.6 to 66.4	—
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. B/Florida/04/2006 (220, 221, 0, 0)	61.1 Titers Interval 52.5 to 71.2	54.8 Titers Interval 47.5 to 63.3	NA Titers B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group	—

PRIMARY outcome

Timeframe: Day 21 post-vaccination

Population: Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. B/Brisbane/60/2008 (220, 221, 0, 0)	73.8 Titers Interval 63.9 to 85.3	42.2 Titers Interval 36.5 to 48.7	NA Titers B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group	—
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. B/Florida/04/2006 (220, 0, 219, 0)	61.1 Titers Interval 52.5 to 71.2	NA Titers B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group	28.5 Titers Interval 24.6 to 33.0	—

PRIMARY outcome

Timeframe: Day 0 and Day 21 post-vaccination

Population: Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=59 Participants Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older A/H1N1, Pre-vaccination	21.7 Titers Interval 17.9 to 26.3	21.1 Titers Interval 17.5 to 25.5	24.8 Titers Interval 20.4 to 30.1	26.7 Titers Interval 17.7 to 40.2
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older A/H1N1, Post-vaccination	231 Titers Interval 188.0 to 283.0	271 Titers Interval 221.0 to 331.0	269 Titers Interval 221.0 to 328.0	728 Titers Interval 515.0 to 1030.0
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older A/H3N2, Pre-vaccination	52.3 Titers Interval 42.1 to 65.0	42.3 Titers Interval 34.9 to 51.4	48.3 Titers Interval 40.0 to 58.4	33.0 Titers Interval 22.1 to 49.1
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older A/H3N2, Post vaccination	501 Titers Interval 422.0 to 593.0	360 Titers Interval 302.0 to 429.0	291 Titers Interval 243.0 to 347.0	503 Titers Interval 361.0 to 701.0
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older B/Brisbane, Pre-vaccination	27.1 Titers Interval 23.3 to 31.5	28.5 Titers Interval 24.2 to 33.6	29.0 Titers Interval 25.0 to 33.7	18.9 Titers Interval 14.0 to 25.4
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older B/Brisbane, Post-vaccination	73.8 Titers Interval 63.9 to 85.3	42.2 Titers Interval 36.5 to 48.7	57.9 Titers Interval 50.6 to 66.4	97.7 Titers Interval 75.0 to 127.0
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older B/Florida, Pre-vaccination	20.2 Titers Interval 17.5 to 23.3	19.7 Titers Interval 17.2 to 22.6	18.7 Titers Interval 16.4 to 21.3	19.5 Titers Interval 14.5 to 26.3
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older B/Florida, Post-vaccination	61.1 Titers Interval 52.5 to 71.2	54.8 Titers Interval 47.5 to 63.3	28.5 Titers Interval 24.6 to 33.0	48.6 Titers Interval 35.5 to 66.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 21 post-vaccination

Population: Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \< 10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. B/Brisbane/60/2008 (220, 0, 219, 0)	63 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group	41 Participants	—
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. B/Florida/04/2006 (220, 221, 0, 0)	73 Participants	69 Participants Interval 0.0 to 0.0	NA Participants Interval 0.0 to 0.0 B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 21 post-vaccination

Population: Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers.

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. B/Brisbane/60/2008 (220, 221, 0, 0)	63 Participants	19 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	—
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. B/Florida/04/2006 (220, 0, 219, 0)	73 Participants	NA Participants Interval 0.0 to 0.0 B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	20 Participants Interval 0.0 to 0.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 21 post-vaccination

Population: Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=59 Participants Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. A/H1N1 Pre-vaccination	70 Participants	70 Participants Interval 0.0 to 0.0	78 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. A/H1N1 Post-vaccination	201 Participants	203 Participants Interval 0.0 to 0.0	200 Participants Interval 0.0 to 0.0	58 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. A/H3N2 Pre-vaccination	129 Participants	119 Participants Interval 0.0 to 0.0	131 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. A/H3N2 Post-vaccination	220 Participants	212 Participants Interval 0.0 to 0.0	209 Participants Interval 0.0 to 0.0	57 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. B/Brisbane Pre-vaccination	101 Participants	108 Participants Interval 0.0 to 0.0	108 Participants Interval 25.0 to 33.7	21 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. B/Brisbane Post-vaccination	171 Participants	133 Participants Interval 0.0 to 0.0	157 Participants Interval 0.0 to 0.0	54 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. B/Florida Pre-vaccination	75 Participants	67 Participants Interval 0.0 to 0.0	68 Participants Interval 0.0 to 0.0	18 Participants Interval 0.0 to 0.0
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. B/Florida Post-vaccination	161 Participants	149 Participants Interval 0.0 to 0.0	101 Participants Interval 0.0 to 0.0	38 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 21 post-vaccination

Population: Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=220 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=221 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=219 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=59 Participants Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older A/A1N1	145 Participants	161 Participants Interval 0.0 to 0.0	146 Participants Interval 0.0 to 0.0	46 Participants Interval 0.0 to 0.0
Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older A/A3N2	152 Participants	139 Participants Interval 0.0 to 0.0	122 Participants Interval 0.0 to 0.0	50 Participants Interval 0.0 to 0.0
Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older B/Brisbane/60/2008	63 Participants	19 Participants Interval 0.0 to 0.0	41 Participants Interval 0.0 to 0.0	27 Participants Interval 0.0 to 0.0
Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older B/Florida/04/2006	73 Participants	69 Participants Interval 0.0 to 0.0	20 Participants Interval 0.0 to 0.0	18 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 up to day 21 post-vaccination

Population: Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.

Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling \>100 mm. Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity.

Outcome measures

Outcome measures
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=225 Participants Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=64 Participants Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Injection site Pain (224, 225, 224, 63)	73 Participants	52 Participants Interval 0.0 to 0.0	64 Participants Interval 0.0 to 0.0	31 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Injection site Pain (224, 225, 224, 63)	2 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Injection site Erythema (224, 224, 224, 63)	6 Participants	3 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Injection site Erythema (224, 224, 224, 63	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Injection site Swelling (224, 224, 224, 63)	4 Participants	0 Participants Interval 0.0 to 0.0	3 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Injection site Swelling (224, 224, 224, 63	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Fever (224, 225, 223, 63)	3 Participants	2 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Fever (224, 225, 223, 63)	1 Participants	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Headache (224, 225, 224, 63)	30 Participants	26 Participants Interval 0.0 to 0.0	26 Participants Interval 0.0 to 0.0	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Headache (224, 225, 224, 63)	1 Participants	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Malaise (224, 225, 224, 63)	24 Participants	26 Participants Interval 0.0 to 0.0	14 Participants Interval 0.0 to 0.0	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade Malaise (224, 225, 224, 63)	1 Participants	2 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Myalgia (224, 225, 224, 63)	41 Participants	32 Participants Interval 0.0 to 0.0	41 Participants Interval 0.0 to 0.0	22 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. Grade 3 Myalgia (224, 225, 224, 63)	1 Participants	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0

Adverse Events

Group 1 (Investigational Quadrivalent Influenza Vaccine)

Serious events: 0 serious events

Other events: 73 other events

Deaths: 0 deaths

Group 2 (Investigational Trivalent Influenza Vaccine)

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Group 3 (Licensed Trivalent Influenza Vaccine)

Serious events: 2 serious events

Other events: 64 other events

Deaths: 0 deaths

Group 4 (Licensed Trivalent Influenza Vaccine)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=64 participants at risk Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Eye disorders Retina detachment	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.44% 1/225 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/64 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
Infections and infestations Cellulitis	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.44% 1/225 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/64 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.44% 1/225 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/225 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/64 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination

Other adverse events

Other adverse events
Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine	Group 2 (Investigational Trivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine	Group 3 (Licensed Trivalent Influenza Vaccine) n=225 participants at risk Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine	Group 4 (Licensed Trivalent Influenza Vaccine) n=64 participants at risk Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
General disorders Injection site pain	32.6% 73/224 • Number of events 73 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	23.1% 52/225 • Number of events 52 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	28.6% 64/224 • Number of events 64 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	49.2% 31/63 • Number of events 31 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
General disorders Injection site Swelling	1.8% 4/224 • Number of events 4 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	0.00% 0/224 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	1.3% 3/224 • Number of events 3 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	7.9% 5/63 • Number of events 5 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
Nervous system disorders Headache	13.4% 30/224 • Number of events 30 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	11.6% 26/224 • Number of events 26 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	11.6% 26/225 • Number of events 26 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	25.4% 16/63 • Number of events 16 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
General disorders Malaise	10.7% 24/224 • Number of events 24 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	6.2% 14/224 • Number of events 14 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	11.6% 26/225 • Number of events 26 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	25.4% 16/63 • Number of events 16 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
Musculoskeletal and connective tissue disorders Myalgia	18.3% 41/224 • Number of events 41 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	14.2% 32/225 • Number of events 32 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	18.3% 41/224 • Number of events 41 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination	34.9% 22/63 • Number of events 22 • Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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Restriction type: OTHER