Trial Outcomes & Findings for Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects (NCT NCT00845429)

NCT ID: NCT00845429

Last Updated: 2012-12-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 729 participants
• Primary outcome timeframe: Days 0 and 21 post-vaccination
• Results posted on: 2012-12-19

Participant Flow

Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.

A total of 729 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Participant milestones

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Study STARTED	244	241	244
Overall Study COMPLETED	230	226	224
Overall Study NOT COMPLETED	14	15	20

Reasons for withdrawal

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Study Protocol Violation	5	4	7
Overall Study Lost to Follow-up	7	9	10
Overall Study Withdrawal by Subject	2	2	2
Overall Study Serious adverse event	0	0	1

Baseline Characteristics

Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Baseline characteristics by cohort

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=244 Participants Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=241 Participants Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=244 Participants Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.	Total n=729 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	244 Participants n=93 Participants	241 Participants n=4 Participants	244 Participants n=27 Participants	729 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	34.4 Years STANDARD_DEVIATION 9.41 • n=93 Participants	34.5 Years STANDARD_DEVIATION 9.18 • n=4 Participants	34.1 Years STANDARD_DEVIATION 9.42 • n=27 Participants	34.3 Years STANDARD_DEVIATION 9.32 • n=483 Participants
Sex: Female, Male Female	158 Participants n=93 Participants	162 Participants n=4 Participants	151 Participants n=27 Participants	471 Participants n=483 Participants
Sex: Female, Male Male	86 Participants n=93 Participants	79 Participants n=4 Participants	93 Participants n=27 Participants	258 Participants n=483 Participants
Region of Enrollment United States	244 participants n=93 Participants	241 participants n=4 Participants	244 participants n=27 Participants	729 participants n=483 Participants

PRIMARY outcome

Timeframe: Days 0 and 21 post-vaccination

Population: Geometric mean titers were assessed in the full analysis set population.

Outcome measures

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=236 Participants Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=233 Participants Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=238 Participants Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. B: Malaysia, Day 21 (nN= 235, 233, 237)	51.1 Titers Interval 43.2 to 60.4	53.0 Titers Interval 45.6 to 61.6	108.6 Titers Interval 95.4 to 123.7
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237)	25.9 Titers Interval 21.0 to 32.0	26.4 Titers Interval 21.6 to 32.4	26.6 Titers Interval 21.7 to 32.5
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238)	184.8 Titers Interval 150.1 to 227.5	226.6 Titers Interval 187.2 to 274.4	425.1 Titers Interval 357.2 to 505.9
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237)	51.2 Titers Interval 41.2 to 63.6	53.4 Titers Interval 43.8 to 65.2	51.5 Titers Interval 41.4 to 64.0
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238)	288.3 Titers Interval 243.1 to 342.0	351.3 Titers Interval 302.2 to 408.5	692.4 Titers Interval 596.3 to 803.9
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. B: Malaysia, Day 0 (N = 236, 233, 238)	13.4 Titers Interval 11.8 to 15.1	14.3 Titers Interval 12.6 to 16.3	14.2 Titers Interval 12.5 to 16.2

PRIMARY outcome

Timeframe: Day 21 post-vaccination

Population: Seroprotection was assessed in the full analysis set population.

Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)

Outcome measures

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=236 Participants Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=233 Participants Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=238 Participants Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237)	40 Percentage of Participants	39 Percentage of Participants	41 Percentage of Participants
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238)	86 Percentage of Participants	90 Percentage of Participants	98 Percentage of Participants
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. A/H3N2: Wisconsin Day 0 (N = 236, 232, 237)	54 Percentage of Participants	62 Percentage of Participants	55 Percentage of Participants
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. A/H3N2: Wisconsin Day 21 (N = 236, 230, 238)	94 Percentage of Participants	98 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. B: Malaysia Day 0 (N = 236, 233, 238)	14 Percentage of Participants	20 Percentage of Participants	20 Percentage of Participants
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. B: Malaysia Day 21 (N = 235, 233, 237)	60 Percentage of Participants	64 Percentage of Participants	87 Percentage of Participants

PRIMARY outcome

Timeframe: Day 21 post-vaccination

Population: Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.

Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.

Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.

Outcome measures

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=236 Participants Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=233 Participants Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=238 Participants Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. A/H1N1: Solomon Islands (N = 236, 231, 237)	54 Percentage of Participants	63 Percentage of Participants	74 Percentage of Participants
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. A/H3N2: Wisconsin (N = 236, 230, 237)	50 Percentage of Participants	53 Percentage of Participants	71 Percentage of Participants
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. B: Malaysia (N = 235, 233, 237)	38 Percentage of Participants	38 Percentage of Participants	61 Percentage of Participants

SECONDARY outcome

Timeframe: Day 0 up to Day 7 post-vaccination

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

Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.

Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.

Outcome measures

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=244 Participants Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=241 Participants Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=244 Participants Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Ecchymosis (≥ 5 cm)	0 Participants	0 Participants	1 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Solicited Injection Site Reaction	117 Participants	156 Participants	184 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Pain	103 Participants	144 Participants	175 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Pain (incapacitating, prevents activities)	1 Participants	2 Participants	1 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Erythema	36 Participants	57 Participants	55 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Erythema (≥ 5 cm)	0 Participants	0 Participants	4 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Swelling	24 Participants	23 Participants	36 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Swelling (≥ 5 cm)	0 Participants	0 Participants	1 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Ecchymosis	6 Participants	19 Participants	14 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Induration	31 Participants	29 Participants	38 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Induration (≥ 5 cm)	0 Participants	0 Participants	0 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Solicited Systemic Reaction	114 Participants	126 Participants	137 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Fever (39.0 ºC or 102.2 ºF)	0 Participants	0 Participants	2 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Headache	75 Participants	85 Participants	89 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Headache (Prevents daily activities)	3 Participants	3 Participants	6 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Malaise	58 Participants	54 Participants	63 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Myalgia	60 Participants	70 Participants	83 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Myalgia (Prevents daily activities)	1 Participants	3 Participants	4 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Rigors	16 Participants	9 Participants	13 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Rigors (Prevents daily activities)	2 Participants	1 Participants	1 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Grade 3 Malaise (Prevents daily activities)	6 Participants	4 Participants	5 Participants
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. Any Fever	13 Participants	9 Participants	11 Participants

Adverse Events

Group 1: Standard Dose Cell-Based Influenza Vaccine

Serious events: 3 serious events

Other events: 158 other events

Deaths: 0 deaths

Group 2: High-dose Cell-Based Influenza Vaccine

Serious events: 4 serious events

Other events: 179 other events

Deaths: 0 deaths

Group 3: Licensed Fluzone® Influenza Vaccine

Serious events: 6 serious events

Other events: 199 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=244 participants at risk Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=241 participants at risk Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=244 participants at risk Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Hepatobiliary disorders Biliary Dyskinesia	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Hepatobiliary disorders Gallbladder Non-functioning	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/241 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Infections and infestations Diverticulitis	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Infections and infestations Gastroenteritis	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Injury, poisoning and procedural complications Gastrointestinal Stoma Complication	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/241 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/241 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Metabolism and nutrition disorders Dehydration	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Nervous system disorders Loss of Consciousness	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/241 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Psychiatric disorders Depression	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Renal and urinary disorders Nephrolithiasis	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/241 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Reproductive system and breast disorders Ovarian Cyst Ruptured	0.00% 0/244 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.00% 0/241 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	0.41% 1/244 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.

Other adverse events

Measure	Group 1: Standard Dose Cell-Based Influenza Vaccine n=244 participants at risk Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.	Group 2: High-dose Cell-Based Influenza Vaccine n=241 participants at risk Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.	Group 3: Licensed Fluzone® Influenza Vaccine n=244 participants at risk Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
General disorders Injection site Pain	42.9% 103/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	61.5% 144/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	73.5% 175/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Injection site Erythema	15.0% 36/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	24.4% 57/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	23.1% 55/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Injection site Swelling	10.0% 24/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	9.8% 23/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	15.1% 36/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Injection site Ecchymosis	2.5% 6/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	8.1% 19/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	5.9% 14/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Injection site Induration	12.9% 31/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	12.4% 29/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	16.0% 38/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Fever	5.4% 13/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	3.8% 9/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	4.6% 11/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Malaise	24.2% 58/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	23.1% 54/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	26.5% 63/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
General disorders Rigors	6.7% 16/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	3.8% 9/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	5.5% 13/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 60/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	29.9% 70/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	34.9% 83/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Nervous system disorders Headache	31.2% 75/240 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	36.3% 85/234 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.	37.4% 89/238 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

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