Trial Outcomes & Findings for Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults (NCT NCT00772109)

NCT ID: NCT00772109

Last Updated: 2016-04-14

Results Overview

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4292 participants

Primary outcome timeframe

Baseline (Day 0) and 28 Days post-vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 13 through 30 October 2008 in 50 clinics in the US.

A total of 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.

Participant milestones

Participant milestones
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Study STARTED	956	953	955	1428
Overall Study COMPLETED	935	934	936	1397
Overall Study NOT COMPLETED	21	19	19	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Overall Study Serious adverse event	1	0	1	0
Overall Study Protocol Violation	5	8	7	6
Overall Study Lost to Follow-up	7	3	5	9
Overall Study Withdrawal by Subject	8	8	6	16

Baseline Characteristics

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=956 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=953 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=955 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1428 Participants Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0	Total n=4292 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	956 Participants n=5 Participants	953 Participants n=7 Participants	955 Participants n=5 Participants	1428 Participants n=4 Participants	4292 Participants n=21 Participants
Age, Categorical >=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, Continuous	42.7 Years STANDARD_DEVIATION 13.41 • n=5 Participants	42.8 Years STANDARD_DEVIATION 13.33 • n=7 Participants	42.2 Years STANDARD_DEVIATION 13.78 • n=5 Participants	42.5 Years STANDARD_DEVIATION 13.55 • n=4 Participants	42.5 Years STANDARD_DEVIATION 13.5175 • n=21 Participants
Sex: Female, Male Female	611 Participants n=5 Participants	619 Participants n=7 Participants	594 Participants n=5 Participants	899 Participants n=4 Participants	2723 Participants n=21 Participants
Sex: Female, Male Male	345 Participants n=5 Participants	334 Participants n=7 Participants	361 Participants n=5 Participants	529 Participants n=4 Participants	1569 Participants n=21 Participants
Region of Enrollment United States	956 Participants n=5 Participants	953 Participants n=7 Participants	955 Participants n=5 Participants	1428 Participants n=4 Participants	4292 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) and 28 Days post-vaccination

Population: Geometric Mean Titers (GMTs) were analyzed in the per-protocol population

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay

Outcome measures

Outcome measures
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=863 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=856 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=860 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1286 Participants Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286)	18.77 Titer Interval 17.29 to 20.38	20.56 Titer Interval 18.89 to 22.38	18.37 Titer Interval 16.88 to 19.99	19.99 Titer Interval 18.65 to 21.43
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284)	260.46 Titer Interval 235.49 to 288.09	234.03 Titer Interval 212.13 to 258.21	246.06 Titer Interval 222.65 to 271.93	230.71 Titer Interval 213.75 to 249.03
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines B (Pre-vaccination, N = 862, 855, 860, 1286)	23.77 Titer Interval 22.03 to 25.63	25.59 Titer Interval 23.69 to 27.64	24.24 Titer Interval 22.51 to 26.1	25.05 Titer Interval 23.53 to 26.68
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines B (Post-vaccination, N = 861, 856, 860, 1285)	103.72 Titer Interval 96.61 to 111.35	102.91 Titer Interval 95.88 to 110.46	100.82 Titer Interval 93.95 to 108.2	126.91 Titer Interval 119.7 to 134.56
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285)	23.50 Titer Interval 21.58 to 25.6	25.27 Titer Interval 23.16 to 27.58	25.29 Titer Interval 23.2 to 27.56	24.84 Titer Interval 23.16 to 26.65
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283)	188.56 Titer Interval 172.67 to 205.92	185.59 Titer Interval 169.81 to 202.83	206.10 Titer Interval 188.53 to 225.31	178.30 Titer Interval 166.36 to 191.11

PRIMARY outcome

Timeframe: 28 Days post-vaccination

Population: Seroprotection was analyzed in the per-protocol population

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.

Outcome measures

Outcome measures
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=863 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=856 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=860 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1286 Participants Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H1N1 Serogroup	61 Percentage of Participants	59 Percentage of Participants	63 Percentage of Participants	61 Percentage of Participants
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H3N2 Serogroup	76 Percentage of Participants	73 Percentage of Participants	77 Percentage of Participants	75 Percentage of Participants
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine B Serogroup	47 Percentage of Participants	45 Percentage of Participants	47 Percentage of Participants	54 Percentage of Participants

SECONDARY outcome

Timeframe: Before and 28 Days post-vaccination

Population: 4-Fold increase in antibody levels were analyzed in h per-protocol population

The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=863 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=857 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=861 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1287 Participants Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM A/H1N1 Serogroup (Pre-vaccination)	39 Percentage of Participants	40 Percentage of Participants	42 Percentage of Participants	39 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM A/H1N1 Serogroup (Post-vaccination)	90 Percentage of Participants	90 Percentage of Participants	93 Percentage of Participants	92 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM A/H3N2 Serogroup (Pre-vaccination)	31 Percentage of Participants	32 Percentage of Participants	30 Percentage of Participants	34 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM A/H3N2 Serogroup (Post-vaccination)	92 Percentage of Participants	90 Percentage of Participants	91 Percentage of Participants	91 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM B Serogroup (Pre-vaccination)	38 Percentage of Participants	42 Percentage of Participants	40 Percentage of Participants	41 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM B Serogroup (Post-vaccination)	88 Percentage of Participants	88 Percentage of Participants	86 Percentage of Participants	89 Percentage of Participants

SECONDARY outcome

Timeframe: Day 0 up to 7 Days post vaccination

Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population

Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.

Outcome measures

Outcome measures
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=953 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=951 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=951 Participants Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1421 Participants Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Ecchymosis	81 Participants	82 Participants	97 Participants	86 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Ecchymosis (≥ 5 cm)	8 Participants	2 Participants	2 Participants	6 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Erythema	716 Participants	698 Participants	726 Participants	184 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Erythema (≥ 5 cm)	125 Participants	118 Participants	120 Participants	13 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Induration	554 Participants	533 Participants	547 Participants	139 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Induration (≥ 5 cm)	36 Participants	19 Participants	41 Participants	7 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Pain	480 Participants	449 Participants	500 Participants	749 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Pain (Incapacitating)	3 Participants	6 Participants	9 Participants	11 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Pruritus	447 Participants	430 Participants	438 Participants	129 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Pruritus (Incapacitating)	13 Participants	10 Participants	7 Participants	0 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Injection Site Swelling	544 Participants	525 Participants	519 Participants	117 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Injection Site Swelling (≥ 5 cm)	55 Participants	45 Participants	52 Participants	13 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Fever	29 Participants	40 Participants	40 Participants	36 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Solicited Fever (> 102.2°F)	2 Participants	0 Participants	0 Participants	3 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Headache	282 Participants	279 Participants	314 Participants	422 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Gr 3 Solicited Headache- Prevents daily activities	11 Participants	16 Participants	14 Participants	22 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Malaise	212 Participants	202 Participants	239 Participants	309 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grd 3 Solicited Malaise- Prevents daily activities	19 Participants	26 Participants	17 Participants	25 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Myalgia	252 Participants	229 Participants	260 Participants	430 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Grd 3 Solicited Myalgia- Prevents daily activities	13 Participants	18 Participants	10 Participants	19 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Shivering	71 Participants	56 Participants	77 Participants	87 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine Gr 3 Solicited Shivering-Prevents daily activities	7 Participants	8 Participants	6 Participants	9 Participants

Adverse Events

Fluzone Intradermal (ID) Vaccine Lot 1

Serious events: 17 serious events

Other events: 716 other events

Deaths: 0 deaths

Fluzone Intradermal (ID) Vaccine Lot 2

Serious events: 16 serious events

Other events: 698 other events

Deaths: 0 deaths

Fluzone Intradermal (ID) Vaccine Lot 3

Serious events: 14 serious events

Other events: 726 other events

Deaths: 0 deaths

Fluzone Intramuscular (IM) Vaccine

Serious events: 20 serious events

Other events: 749 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n=953 participants at risk Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 2 n=951 participants at risk Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Fluzone Intradermal (ID) Vaccine Lot 3 n=951 participants at risk Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Fluzone Intramuscular (IM) Vaccine n=1421 participants at risk Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
General disorders Injection site ecchymosis	8.7% 81/935 • Number of events 81 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	8.8% 82/935 • Number of events 82 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	10.4% 97/929 • Number of events 97 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	6.2% 86/1392 • Number of events 86 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Injection site erythema	76.5% 716/936 • Number of events 716 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	74.7% 698/935 • Number of events 698 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	78.1% 726/930 • Number of events 726 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	13.2% 184/1393 • Number of events 184 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Injection site induration	59.3% 554/934 • Number of events 554 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	57.0% 533/935 • Number of events 533 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	58.9% 547/929 • Number of events 547 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	10.0% 139/1392 • Number of events 139 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Injection site pain	51.3% 480/936 • Number of events 480 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	48.0% 449/935 • Number of events 449 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	53.7% 500/931 • Number of events 500 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	53.7% 749/1394 • Number of events 749 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Injection site pruritus	47.8% 447/936 • Number of events 447 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	46.0% 430/935 • Number of events 430 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	47.0% 438/931 • Number of events 438 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	9.3% 129/1394 • Number of events 129 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Injection site swelling	58.2% 544/934 • Number of events 544 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	56.1% 525/935 • Number of events 525 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	55.9% 519/929 • Number of events 519 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	8.4% 117/1392 • Number of events 117 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Nervous system disorders Solicited Headache	30.1% 282/936 • Number of events 282 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	29.8% 279/935 • Number of events 279 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	33.8% 314/930 • Number of events 314 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	30.3% 422/1394 • Number of events 422 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
General disorders Solicited Malaise	22.6% 212/936 • Number of events 212 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	21.6% 202/935 • Number of events 202 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	25.7% 239/930 • Number of events 239 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	22.2% 309/1394 • Number of events 309 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Solicited Myalgia	26.9% 252/936 • Number of events 252 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	24.5% 229/935 • Number of events 229 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	28.0% 260/930 • Number of events 260 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	30.8% 430/1394 • Number of events 430 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Solicited Shivering	7.6% 71/936 • Number of events 71 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	6.0% 56/935 • Number of events 56 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	8.3% 77/930 • Number of events 77 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.	6.2% 87/1394 • Number of events 87 • Adverse events data were collected from the day of vaccination for up to 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.
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