Trial Outcomes & Findings for Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM (NCT NCT01011049)

Last Updated: 2016-04-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1250 participants

Primary outcome timeframe

Day 0 through Day 7 post-vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled and from 23 September 2009 to 16 October 2009 in 46 medical centers in the US.

A total of 1248 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	Group 1: Fluzone ID After Fluzone ID Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Overall Study STARTED	507	252	243	246
Overall Study COMPLETED	506	250	239	246
Overall Study NOT COMPLETED	1	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Fluzone ID After Fluzone ID Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
Overall Study Protocol Violation	0	0	2
Overall Study Lost to Follow-up	1	2	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Fluzone ID After Fluzone ID n=507 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=252 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=243 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=246 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)	Total n=1248 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	507 Participants n=5 Participants	252 Participants n=7 Participants	242 Participants n=5 Participants	246 Participants n=4 Participants	1247 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	45.2 Years STANDARD_DEVIATION 13.10 • n=5 Participants	44.8 Years STANDARD_DEVIATION 13.26 • n=7 Participants	45.8 Years STANDARD_DEVIATION 12.74 • n=5 Participants	43.7 Years STANDARD_DEVIATION 12.78 • n=4 Participants	45 Years STANDARD_DEVIATION 13 • n=21 Participants
Sex: Female, Male Female	324 Participants n=5 Participants	161 Participants n=7 Participants	158 Participants n=5 Participants	155 Participants n=4 Participants	798 Participants n=21 Participants
Sex: Female, Male Male	183 Participants n=5 Participants	91 Participants n=7 Participants	85 Participants n=5 Participants	91 Participants n=4 Participants	450 Participants n=21 Participants
Region of Enrollment United States	507 Participants n=5 Participants	252 Participants n=7 Participants	243 Participants n=5 Participants	246 Participants n=4 Participants	1248 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 7 post-vaccination

Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.

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

Outcome measures

Outcome measures
Measure	Group 1: Fluzone ID After Fluzone ID n=505 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=249 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=243 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=245 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Headache	148 Participants	65 Participants	72 Participants	73 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Headache (Prevents Daily Activities)	13 Participants	4 Participants	3 Participants	5 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Myalgia	131 Participants	77 Participants	75 Participants	68 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Myalgia (Prevents Daily Activities)	8 Participants	5 Participants	0 Participants	7 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Malaise	98 Participants	55 Participants	50 Participants	54 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Malaise (Prevents Daily Activities)	16 Participants	9 Participants	4 Participants	7 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Shivering	50 Participants	15 Participants	19 Participants	25 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Shivering (Prevents Daily Activities)	8 Participants	0 Participants	0 Participants	5 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Fever	20 Participants	8 Participants	9 Participants	15 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Fever (> 102.2 ºF)	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Erythema	412 Participants	54 Participants	27 Participants	183 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Erythema (≥ 5 cm)	91 Participants	2 Participants	0 Participants	37 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Swelling	343 Participants	45 Participants	13 Participants	137 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Swelling (≥ 5 cm)	40 Participants	4 Participants	2 Participants	14 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Induration	310 Participants	46 Participants	27 Participants	133 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Induration (≥ 5 cm)	24 Participants	0 Participants	1 Participants	11 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Pain	274 Participants	148 Participants	147 Participants	145 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Pain (Incapacitating)	5 Participants	4 Participants	2 Participants	2 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Pruritus	257 Participants	32 Participants	20 Participants	123 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Pruritus (Incapacitating)	10 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Any Solicited Injection Site Ecchymosis	53 Participants	10 Participants	10 Participants	25 Participants
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine Grade 3 Ecchymosis (≥ 5 cm)	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 28 post-vaccination

Population: Serum antibody geometric mean titers were assessed in the per-protocol population.

Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.

Outcome measures

Outcome measures
Measure	Group 1: Fluzone ID After Fluzone ID n=495 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=242 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=234 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=240 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239)	54.5 Titers Interval 48.8 to 60.8	64.8 Titers Interval 55.5 to 75.7	51.2 Titers Interval 43.4 to 60.5	56.3 Titers Interval 48.7 to 65.1
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239)	142.8 Titers Interval 129.7 to 157.3	151.7 Titers Interval 132.1 to 174.3	126.2 Titers Interval 109.4 to 145.7	137.4 Titers Interval 119.8 to 157.5
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239)	78.8 Titers Interval 69.3 to 89.5	91.3 Titers Interval 75.2 to 110.8	69.7 Titers Interval 57.9 to 84.0	79.7 Titers Interval 66.9 to 94.8
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239)	286.7 Titers Interval 260.3 to 315.8	292.0 Titers Interval 250.9 to 339.8	268.3 Titers Interval 234.2 to 307.3	290.8 Titers Interval 252.2 to 335.3
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine B Pre-dose (Day 0; N = 495, 242, 234, 240)	20.1 Titers Interval 18.5 to 21.9	21.0 Titers Interval 18.6 to 23.6	21.0 Titers Interval 18.4 to 24.0	21.8 Titers Interval 19.3 to 24.7
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine B Post-dose (Day 28; N = 495, 242, 234, 240)	75.0 Titers Interval 68.9 to 81.7	85.7 Titers Interval 75.5 to 97.3	73.9 Titers Interval 64.8 to 84.1	72.2 Titers Interval 63.1 to 82.7

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Serum antibody titers were assessed in the per-protocol population.

Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.

Outcome measures

Outcome measures
Measure	Group 1: Fluzone ID After Fluzone ID n=495 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=242 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=234 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=240 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. A/H1N1 Pre-dose (Day 0; N = 495, 242, 234, 239)	64 Percentage of Participants	70 Percentage of Participants	60 Percentage of Participants	67 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. A/H1N1 Post-dose (Day 28; N = 495, 242, 234, 239)	92 Percentage of Participants	94 Percentage of Participants	92 Percentage of Participants	90 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. A/H3N2 Pre-dose (Day 0; N = 495, 242, 234, 239)	71 Percentage of Participants	76 Percentage of Participants	68 Percentage of Participants	71 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. A/H3N2 Post-dose (Day 28; N = 495, 242, 234, 239)	98 Percentage of Participants	96 Percentage of Participants	98 Percentage of Participants	97 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. B Pre-dose (Day 0; N = 495, 242, 234, 240)	32 Percentage of Participants	32 Percentage of Participants	32 Percentage of Participants	33 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. B Post-dose (Day 28; N = 495, 242, 234, 240)	83 Percentage of Participants	84 Percentage of Participants	79 Percentage of Participants	78 Percentage of Participants

SECONDARY outcome

Timeframe: Day 28 post vaccination

Population: Serum antibody titers were assessed in the per protocol population.

Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.

Outcome measures

Outcome measures
Measure	Group 1: Fluzone ID After Fluzone ID n=495 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=242 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=234 Participants Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=240 Participants Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H1N1 Serogroup (N = 495, 242, 234, 239)	31 Percentage of Participants	29 Percentage of Participants	26 Percentage of Participants	30 Percentage of Participants
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine A/H3N2 Serogroup (N = 495, 242, 234, 239)	47 Percentage of Participants	40 Percentage of Participants	42 Percentage of Participants	44 Percentage of Participants
Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine B Serogroup (N = 495, 242, 234, 240)	42 Percentage of Participants	46 Percentage of Participants	42 Percentage of Participants	35 Percentage of Participants

Adverse Events

Group 1: Fluzone ID After Fluzone ID

Serious events: 9 serious events

Other events: 412 other events

Deaths: 0 deaths

Group 2: Fluzone IM After Fluzone ID

Serious events: 2 serious events

Other events: 148 other events

Deaths: 0 deaths

Group 3: Fluzone IM After Fluzone IM

Serious events: 3 serious events

Other events: 147 other events

Deaths: 0 deaths

Group 4: Fluzone ID After Fluzone IM

Serious events: 5 serious events

Other events: 183 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Fluzone ID After Fluzone ID n=507 participants at risk Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=252 participants at risk Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=243 participants at risk Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=246 participants at risk Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
General disorders Injection site erythema	81.6% 412/505 • Number of events 412 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	21.7% 54/249 • Number of events 54 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	11.2% 27/240 • Number of events 27 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	74.7% 183/245 • Number of events 183 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
General disorders Injection site swelling	67.9% 343/505 • Number of events 343 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	18.1% 45/249 • Number of events 45 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	5.4% 13/240 • Number of events 13 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	55.9% 137/245 • Number of events 137 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
General disorders Injection site induration	61.4% 310/505 • Number of events 310 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	18.5% 46/249 • Number of events 46 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	11.2% 27/240 • Number of events 27 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	54.3% 133/245 • Number of events 133 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Gastrointestinal disorders Injection site pain	54.3% 274/505 • Number of events 274 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	59.4% 148/249 • Number of events 148 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	61.3% 147/240 • Number of events 147 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	59.2% 145/245 • Number of events 145 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Skin and subcutaneous tissue disorders Injection site pruritus	50.9% 257/505 • Number of events 257 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	12.9% 32/249 • Number of events 32 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	8.3% 20/240 • Number of events 20 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	50.2% 123/245 • Number of events 123 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Vascular disorders Injection site ecchymosis	10.5% 53/505 • Number of events 53 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	4.0% 10/249 • Number of events 10 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	4.2% 10/240 • Number of events 10 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	10.2% 25/245 • Number of events 25 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
General disorders Malaise	19.4% 98/505 • Number of events 98 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	22.1% 55/249 • Number of events 55 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	20.8% 50/240 • Number of events 50 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	22.0% 54/245 • Number of events 54 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
General disorders Shivering	9.9% 50/505 • Number of events 50 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	6.0% 15/249 • Number of events 15 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	7.9% 19/240 • Number of events 19 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	10.2% 25/245 • Number of events 25 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
General disorders Fever	4.0% 20/505 • Number of events 20 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	3.2% 8/249 • Number of events 8 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	3.8% 9/240 • Number of events 9 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	6.1% 15/245 • Number of events 15 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	25.9% 131/505 • Number of events 131 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	30.9% 77/249 • Number of events 77 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	31.2% 75/240 • Number of events 75 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	27.8% 68/245 • Number of events 245 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Nervous system disorders Headache	29.3% 148/505 • Number of events 148 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	26.1% 65/249 • Number of events 65 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	30.0% 72/240 • Number of events 72 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	29.8% 73/245 • Number of events 73 • 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
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: Fluzone ID After Fluzone ID n=507 participants at risk Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)	Group 2: Fluzone IM After Fluzone ID n=252 participants at risk Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)	Group 3: Fluzone IM After Fluzone IM n=243 participants at risk Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)	Group 4: Fluzone ID After Fluzone IM n=246 participants at risk Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
Endocrine disorders Autoimmune thyroiditis	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Hepatobiliary disorders Cholelithiasis	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Infections and infestations Appendicitis perforated	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Infections and infestations Gastroenteritis	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.40% 1/252 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Infections and infestations Pneumonia	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Infections and infestations Viral infection	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumor	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/243 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Psychiatric disorders Affective disorder	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Psychiatric disorders Psychiatric decompensation	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/243 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Reproductive system and breast disorders Cervix haemorrhage uterine	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.39% 2/507 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Musculoskeletal and connective tissue disorders Knee arthroplasty	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/243 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Musculoskeletal and connective tissue disorders Spinal operation	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Vascular disorders Arteriovenous fistula	0.00% 0/507 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.40% 1/252 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Vascular disorders Embolism venous	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.
Vascular disorders Hypertension	0.20% 1/507 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/252 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/243 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.	0.00% 0/246 • Adverse events data were collected from the day of vaccination for up to 6 months, post-vaccination.