Trial Outcomes & Findings for Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly (NCT NCT00391053)

Last Updated: 2016-04-14

Results Overview

Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3851 participants

Primary outcome timeframe

Day 0 and Day 28 Post-vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 09 October 2006 to 21 December 2006 at 30 US sites.

A total of 3851 participants who met the inclusion and exclusion criteria were randomized and vaccinated. The vaccine received by 14 participants could not be verified, they were excluded from all analyses except immunogenicity analysis. 4 participants that started the study, but had no post-vaccination assessment were also excluded from analysis.

Participant milestones

Participant milestones
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Study STARTED	857	848	870	1262
Overall Study COMPLETED	848	847	868	1252
Overall Study NOT COMPLETED	9	1	2	10

Reasons for withdrawal

Reasons for withdrawal
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Overall Study Serious Adverse Events	1	0	1	4
Overall Study Protocol Violation	2	0	0	0
Overall Study Lost to Follow-up	1	0	0	5
Overall Study Withdrawal by Subject	5	1	1	1

Baseline Characteristics

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=855 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=848 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=870 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) n=1260 Participants Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation	Total n=3833 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	855 Participants n=5 Participants	848 Participants n=7 Participants	870 Participants n=5 Participants	1260 Participants n=4 Participants	3833 Participants n=21 Participants
Age, Continuous	72.9 Years STANDARD_DEVIATION 6.15 • n=5 Participants	72.9 Years STANDARD_DEVIATION 6.20 • n=7 Participants	72.9 Years STANDARD_DEVIATION 6.17 • n=5 Participants	72.9 Years STANDARD_DEVIATION 5.99 • n=4 Participants	72.9 Years STANDARD_DEVIATION 6.17 • n=21 Participants
Sex: Female, Male Female	437 Participants n=5 Participants	438 Participants n=7 Participants	445 Participants n=5 Participants	688 Participants n=4 Participants	2008 Participants n=21 Participants
Sex: Female, Male Male	418 Participants n=5 Participants	410 Participants n=7 Participants	425 Participants n=5 Participants	572 Participants n=4 Participants	1825 Participants n=21 Participants
Region of Enrollment United States	855 participants n=5 Participants	848 participants n=7 Participants	870 participants n=5 Participants	1260 participants n=4 Participants	3833 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 and Day 28 Post-vaccination

Population: The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.

Outcome measures

Outcome measures
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=854 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) n=1275 Participants Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. A/H1N1 New Caledonia Pre-Dose	28.25 Titers Interval 26.37 to 30.26	29.41 Titers Interval 27.39 to 31.57	27.86 Titers Interval 25.94 to 29.93	29.36 Titers Interval 27.72 to 31.11
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. B/Malaysia Pre-Dose	19.24 Titers Interval 17.98 to 20.58	18.96 Titers Interval 17.71 to 20.29	19.78 Titers Interval 18.49 to 21.16	18.96 Titers Interval 17.93 to 20.04
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. A/H1N1 New Caledonia Post-Dose	112.77 Titers Interval 105.64 to 120.37	114.63 Titers Interval 107.18 to 122.61	120.02 Titers Interval 112.12 to 128.48	67.29 Titers Interval 63.65 to 71.13
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. A/H3N2 Wisconsin Pre-Dose	74.53 Titers Interval 67.29 to 82.55	77.3 Titers Interval 69.5 to 85.97	72.07 Titers Interval 65.12 to 79.77	74.74 Titers Interval 68.64 to 81.37
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. A/H3N2 Wisconsin Post-Dose	595.03 Titers Interval 552.8 to 640.49	628.54 Titers Interval 583.21 to 677.4	603.59 Titers Interval 561.33 to 649.03	332.46 Titers Interval 310.44 to 356.05
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. B/Malaysia Post-Dose	68.98 Titers Interval 64.77 to 73.47	69.26 Titers Interval 64.99 to 73.81	68.93 Titers Interval 64.81 to 73.3	52.34 Titers Interval 49.48 to 55.35

PRIMARY outcome

Timeframe: Day 28 Post-vaccination

Population: The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.

Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer \<10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).

Outcome measures

Outcome measures
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=854 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) n=1275 Participants Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H1N1 New Caledonia	47 Percentage of Participants	47 Percentage of Participants	52 Percentage of Participants	23 Percentage of Participants
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H3N2 Wisconsin	70 Percentage of Participants	68 Percentage of Participants	70 Percentage of Participants	51 Percentage of Participants
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. B/Malaysia	43 Percentage of Participants	41 Percentage of Participants	42 Percentage of Participants	30 Percentage of Participants

SECONDARY outcome

Timeframe: Day 0 and Day 28 Post-vaccination

Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.

Outcome measures

Outcome measures
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=854 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=861 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) n=1275 Participants Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H1N1 New Caledonia Pre-Dose	44 Percentage of Participants	46 Percentage of Participants	42 Percentage of Participants	46 Percentage of Participants
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H1N1 New Caledonia Post-Dose	91 Percentage of Participants	89 Percentage of Participants	90 Percentage of Participants	77 Percentage of Participants
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H3N2 Wisconsin Pre-Dose	70 Percentage of Participants	69 Percentage of Participants	68 Percentage of Participants	69 Percentage of Participants
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. A/H3N2 Wisconsin Post-Dose	99 Percentage of Participants	99 Percentage of Participants	99 Percentage of Participants	97 Percentage of Participants
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. B/Malaysia Pre-Dose	27 Percentage of Participants	28 Percentage of Participants	30 Percentage of Participants	27 Percentage of Participants
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines. B/Malaysia Post-Dose	80 Percentage of Participants	78 Percentage of Participants	80 Percentage of Participants	68 Percentage of Participants

SECONDARY outcome

Timeframe: Day 0 to Day 7 Post-vaccination

Population: The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.

The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.

Outcome measures

Outcome measures
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=855 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=848 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=870 Participants Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3	Active Comparator (Standard Fluzone®) n=1260 Participants Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Pain (Incapacitating)	1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Malaise	20 Percentage of Participants	18 Percentage of Participants	16 Percentage of Participants	14 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Myalgia (Prevents Daily Activities)	1 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Solicited Injection Site Reaction	41 Percentage of Participants	42 Percentage of Participants	43 Percentage of Participants	31 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Swelling	9 Percentage of Participants	9 Percentage of Participants	9 Percentage of Participants	6 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Swelling (≥ 5 cm)	1 Percentage of Participants	2 Percentage of Participants	1 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Erythema	16 Percentage of Participants	15 Percentage of Participants	14 Percentage of Participants	11 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Erythema (≥ 5 cm)	3 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Pain	35 Percentage of Participants	34 Percentage of Participants	38 Percentage of Participants	24 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Solicited Systemic Reaction	37 Percentage of Participants	33 Percentage of Participants	33 Percentage of Participants	29 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Fever	4 Percentage of Participants	3 Percentage of Participants	4 Percentage of Participants	2 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Fever (>102.2 ºF or >39.0 ºC)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Headache	17 Percentage of Participants	16 Percentage of Participants	17 Percentage of Participants	14 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Headache (Prevents Daily Activities)	1 Percentage of Participants	2 Percentage of Participants	1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Grade 3 Malaise (Prevents Daily Activities)	1 Percentage of Participants	2 Percentage of Participants	2 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination Any Myalgia	23 Percentage of Participants	21 Percentage of Participants	21 Percentage of Participants	18 Percentage of Participants

Adverse Events

High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1

Serious events: 56 serious events

Other events: 455 other events

Deaths: 0 deaths

High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2

Serious events: 56 serious events

Other events: 454 other events

Deaths: 0 deaths

High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3

Serious events: 44 serious events

Other events: 449 other events

Deaths: 0 deaths

Standad Dose Inactivated, Split-Virion Influenza Vaccine

Serious events: 93 serious events

Other events: 544 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n=855 participants at risk	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n=848 participants at risk	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n=870 participants at risk	Standad Dose Inactivated, Split-Virion Influenza Vaccine n=1260 participants at risk
General disorders Injection site erythema	15.9% 136/855 • Number of events 136 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	14.7% 125/848 • Number of events 125 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	14.1% 123/870 • Number of events 123 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	10.8% 136/1260 • Number of events 136 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
General disorders Injection site pain	34.5% 295/855 • Number of events 295 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	34.4% 292/848 • Number of events 292 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	37.7% 328/870 • Number of events 328 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	24.3% 306/1260 • Number of events 306 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
General disorders Injection site swelling	9.2% 79/855 • Number of events 79 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	9.0% 76/848 • Number of events 76 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	8.6% 75/870 • Number of events 75 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	5.8% 73/1260 • Number of events 73 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
General disorders Malaise	20.2% 173/855 • Number of events 173 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	17.7% 150/848 • Number of events 150 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	16.0% 139/870 • Number of events 139 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	14.0% 176/1260 • Number of events 176 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
Musculoskeletal and connective tissue disorders Myalgia	23.0% 197/855 • Number of events 197 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	20.6% 175/848 • Number of events 175 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	20.5% 178/870 • Number of events 178 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	18.3% 230/1260 • Number of events 230 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination
Nervous system disorders Headache	17.1% 146/855 • Number of events 146 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	16.3% 138/848 • Number of events 138 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	16.9% 147/870 • Number of events 147 • Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination	14.4% 182/1260 • Number of events 182 • Adverse events data were collected from day of vaccination (Day 0) for 6 months 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.
Publication restrictions are in place

Restriction type: OTHER