Trial Outcomes & Findings for Jet Injection for Influenza (NCT NCT01688921)

NCT ID: NCT01688921

Last Updated: 2017-11-01

Results Overview

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1250 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-11-01

Participant Flow

Participant milestones

Measure	STRATIS Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device	Needle-Syringe Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Overall Study STARTED	627	623
Overall Study COMPLETED	611	608
Overall Study NOT COMPLETED	16	15

Reasons for withdrawal

Measure	STRATIS Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device	Needle-Syringe Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Overall Study Lost to Follow-up	7	13
Overall Study Physician Decision	6	1
Overall Study Protocol Violation	0	1
Overall Study informed consent	3	0

Baseline Characteristics

Jet Injection for Influenza

Baseline characteristics by cohort

Measure	STRATIS n=624 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device	Needle-Syringe n=623 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe	Total n=1247 Participants Total of all reporting groups
Age, Continuous	41.3 Years STANDARD_DEVIATION 12.92 • n=5 Participants	41.5 Years STANDARD_DEVIATION 12.49 • n=7 Participants	41.4 Years STANDARD_DEVIATION 12.70 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	624 Participants n=5 Participants	623 Participants n=7 Participants	1247 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	449 Participants n=5 Participants	432 Participants n=7 Participants	881 Participants n=5 Participants
Sex: Female, Male Male	175 Participants n=5 Participants	191 Participants n=7 Participants	366 Participants n=5 Participants
Region of Enrollment United States	624 participants n=5 Participants	623 participants n=7 Participants	1247 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 0	4.43 Titers Standard Deviation 1.348	4.38 Titers Standard Deviation 1.352
Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 28	5.64 Titers Standard Deviation 1.006	5.64 Titers Standard Deviation 0.997

PRIMARY outcome

Timeframe: 28 days

Population: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 0	4.22 Titers Standard Deviation 1.283	4.32 Titers Standard Deviation 1.290
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 28	5.51 Titers Standard Deviation 1.022	5.58 Titers Standard Deviation 0.987

PRIMARY outcome

Timeframe: 28 days

Population: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 0	2.60 Titers Standard Deviation 1.028	2.54 Titers Standard Deviation 1.003
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) Day 28	3.75 Titers Standard Deviation 1.037	3.68 Titers Standard Deviation 1.061

PRIMARY outcome

Timeframe: 28 days

Population: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type A/H1N1 Seroconversion	37.5 Percent of Participants	38.4 Percent of Participants

PRIMARY outcome

Timeframe: 28 days

Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type A/H3N2 Seroconversion	43.8 Percent of Participants	45.1 Percent of Participants

PRIMARY outcome

Timeframe: 28 days

Population: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.

Outcome measures

Measure	PJ STRATIS n=562 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=568 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Anti Influenza Type B Seroconversion	34.9 Percent of Participants	35.2 Percent of Participants

SECONDARY outcome

Timeframe: Within 30 minutes post-vaccination

Population: The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).

Outcome measures

Measure	PJ STRATIS n=624 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=623 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Pain	163 participants	69 participants
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Tenderness	104 participants	36 participants
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Itching	63 participants	17 participants
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Redness	113 participants	11 participants
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Swelling	5 participants	0 participants
Number of Subjects With Complaints Within 30 Minutes Following Vaccination Bruising	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 0, 1, 2, 3, 4, 5, and 6

Population: The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.

Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.

Outcome measures

Measure	PJ STRATIS n=616 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=607 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Number of Subjects With Vaccine Reactogenicity Events Vomiting	8 participants	11 participants
Number of Subjects With Vaccine Reactogenicity Events Pain	397 participants	299 participants
Number of Subjects With Vaccine Reactogenicity Events Tenderness	551 participants	472 participants
Number of Subjects With Vaccine Reactogenicity Events Itching	151 participants	50 participants
Number of Subjects With Vaccine Reactogenicity Events Redness	366 participants	115 participants
Number of Subjects With Vaccine Reactogenicity Events Swelling	392 participants	115 participants
Number of Subjects With Vaccine Reactogenicity Events Bruising	107 participants	32 participants
Number of Subjects With Vaccine Reactogenicity Events Headache	151 participants	133 participants
Number of Subjects With Vaccine Reactogenicity Events Malaise	191 participants	171 participants
Number of Subjects With Vaccine Reactogenicity Events Myalgia	222 participants	214 participants
Number of Subjects With Vaccine Reactogenicity Events Chills	43 participants	43 participants
Number of Subjects With Vaccine Reactogenicity Events Nausea	40 participants	39 participants

SECONDARY outcome

Timeframe: 28 days

Population: The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).

Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.

Outcome measures

Measure	PJ STRATIS n=624 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe n=623 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Number of Subjects With Spontaneously Reported Adverse Events	92 participants with spontaneous AEs	73 participants with spontaneous AEs

SECONDARY outcome

Timeframe: 28 Days

Population: Safety population

Outcome measures

Measure	PJ STRATIS n=624 Participants Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. PJ STRATIS needle-free injection device	Needle-Syringe Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again	89 Percent of Participants	—

Adverse Events

STRATIS

Serious events: 1 serious events

Other events: 586 other events

Deaths: 0 deaths

Needle-Syringe

Serious events: 2 serious events

Other events: 516 other events

Deaths: 0 deaths

Serious adverse events

Measure	STRATIS n=624 participants at risk Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device	Needle-Syringe n=623 participants at risk Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
Gastrointestinal disorders Duodenal Ulcer Perforation	0.16% 1/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.00% 0/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Infections and infestations Peritonitis	0.16% 1/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.00% 0/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Infections and infestations Viral Meningitis	0.00% 0/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.16% 1/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Cardiac disorders Coronary Artery Disease	0.00% 0/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.16% 1/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Cardiac disorders Myocardial Infarction	0.00% 0/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.16% 1/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Cardiac disorders Arterial Injury	0.00% 0/624 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	0.16% 1/623 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.

Other adverse events

Measure	STRATIS n=624 participants at risk Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device	Needle-Syringe n=623 participants at risk Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe
General disorders Pain	64.4% 397/616 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	49.3% 299/606 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
General disorders Tenderness	89.4% 551/616 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	77.7% 471/606 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
General disorders Itching	27.0% 146/540 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	9.3% 49/527 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
General disorders Redness	60.1% 366/609 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	19.2% 115/599 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
General disorders Swelling	64.8% 392/605 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	19.7% 118/599 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
General disorders Bruising	17.1% 104/607 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	5.0% 30/599 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Musculoskeletal and connective tissue disorders Myalgia	36.4% 222/610 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	35.5% 214/602 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Nervous system disorders Headache	24.7% 151/612 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	22.1% 133/603 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Immune system disorders Malaise	31.2% 191/612 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	28.4% 171/602 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Nervous system disorders Chills	7.0% 43/610 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	7.2% 43/601 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Gastrointestinal disorders Nausea	6.6% 40/610 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.	6.5% 39/601 • Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card. The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.

Additional Information

Tara Miller, Clinical Affairs Manager

PharmaJet, Inc.

Phone: 888-900-4321

Email: tara.miller@pharmajet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60