Trial Outcomes & Findings for Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR) (NCT NCT02445963)

NCT ID: NCT02445963

Last Updated: 2021-02-12

Results Overview

Number of adverse events related to the vaccine for each arm

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

38 participants

Primary outcome timeframe

166 days

Results posted on

2021-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	10 μg S. Flexneri 2a Invaplex 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Overall Study STARTED	9	9	10	10
Overall Study COMPLETED	7	9	9	10
Overall Study NOT COMPLETED	2	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	10 μg S. Flexneri 2a Invaplex 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Overall Study Lost to Follow-up	1	0
Overall Study Change in employment	1	0
Overall Study Symptoms post-vaccination	0	1

Baseline Characteristics

Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	Total n=38 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	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
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	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
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	38 participants n=21 Participants
Age, Continuous	24 years n=5 Participants	34 years n=7 Participants	28 years n=5 Participants	28 years n=4 Participants	28 years n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants

PRIMARY outcome

Timeframe: 166 days

Number of adverse events related to the vaccine for each arm

Outcome measures

Outcome measures
Measure	10 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Number of Treatment Related Adverse Events	27 Adverse Events	37 Adverse Events	41 Adverse Events	46 Adverse Events

PRIMARY outcome

Timeframe: At screening and Days 0, 14, 28, 35, 42, and 56

Population: Subjects who received at least 2 vaccine doses were included in the immunology analyses.

Serum samples will be assayed for antibody titers against the immunizing antigens LPS, IpaB, IpaC, and S. flexneri 2a Invaplex at screening, and Days 0, 14, 28, 35, 42, and 56 for 36 subjects. Previously established high-titer specimens will be included on each plate to track day to day interassay variation. For each antigen, pre- and post-vaccination serum samples will be assayed side-by-side. The antibody titer assigned to each sample will represent the geometric mean of duplicate tests performed on 2 different days. Reciprocal endpoint titers \< 5 will be assigned a value of 2.5 for computational purposes. Seroconversion will be defined as a \> 4-fold increase in endpoint titer between pre-and post-vaccination samples AND a post-vaccination reciprocal titer \>10.

Outcome measures

Outcome measures
Measure	10 μg S. Flexneri 2a Invaplex n=8 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=9 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgG (Invaplex)	1345.4 titers Interval 805.0 to 2248.8	4703.2 titers Interval 2104.6 to 10510.2	5486.4 titers Interval 2199.0 to 13688.0	5571.5 titers Interval 2680.3 to 11581.5
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgA (Invaplex)	259.4 titers Interval 108.4 to 620.7	800.0 titers Interval 330.7 to 1935.6	685.8 titers Interval 192.3 to 2445.5	606.3 titers Interval 259.3 to 1417.4
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgG (LPS)	1902.7 titers Interval 1138.4 to 3180.2	4703.2 titers Interval 2434.3 to 9086.5	4703.2 titers Interval 2939.8 to 7524.2	6400 titers Interval 3056.1 to 13402.8
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgA (LPS)	259.4 titers Interval 108.4 to 620.7	635.0 titers Interval 330.6 to 1219.4	544.3 titers Interval 207.5 to 1428.2	527.8 titers Interval 233.3 to 1194.1
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgG (IpaB)	183.4 titers Interval 103.3 to 325.7	740.7 titers Interval 228.8 to 2397.8	342.9 titers Interval 86.4 to 1361.0	229.7 titers Interval 102.9 to 512.8
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgA (IpaB)	50.0 titers The data were not normally distributed	73.5 titers Interval 36.1 to 149.5	85.7 titers Interval 42.8 to 171.5	50.0 titers The data were not normally distributed
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgG (IpaC)	336.4 titers Interval 171.2 to 660.7	2539.8 titers Interval 1049.8 to 6145.1	1728.1 titers Interval 353.8 to 8440.5	2599.2 titers Interval 1049.6 to 6436.6
Antibody Titers Against IgG and IgA Immunizing Antigens Serum IgA (IpaC)	70.7 titers Interval 38.1 to 131.4	317.5 titers Interval 72.0 to 1399.2	272.2 titers Interval 84.9 to 872.2	400.0 titers Interval 144.4 to 1108.0

SECONDARY outcome

Timeframe: 56 Days

Population: Arm 1: One patient was lost to follow-up post dose 1 vaccination, overall participants is therefore 8 for this arm Arm 3: One patient withdrew from the study due to symptoms post dose 1 vaccination, overall participants is therefore 9 for this arm

ASC responses were assessed using isolated peripheral blood mononuclear cells (PBMCs). For each antigen, pre- and post-vaccination samples were tested on the same plates for total and vaccine-specific numbers. The ASC responses indirectly reflect intestinal immune responses through measurement of antigen-specific B-lymphocytes in systemic circulation before homing to gut effector sites. An ASC response was defined as \> 10 ASCs above baseline.

Outcome measures

Outcome measures
Measure	10 μg S. Flexneri 2a Invaplex n=8 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=9 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
IgG and IgA Antigen-Specific Antibody Secreting Cell (ASC) Mucosal Responses ASC IgG (Invaplex)	0.5 ASC per 10^6 PBMCs Interval 0.0 to 4.5	4.0 ASC per 10^6 PBMCs Interval 3.0 to 9.0	5.0 ASC per 10^6 PBMCs Interval 5.0 to 12.0	9.0 ASC per 10^6 PBMCs Interval 4.0 to 17.0
IgG and IgA Antigen-Specific Antibody Secreting Cell (ASC) Mucosal Responses ASC IgA (Invaplex)	1.00 ASC per 10^6 PBMCs Interval 1.0 to 2.0	27.0 ASC per 10^6 PBMCs Interval 20.0 to 96.0	23.0 ASC per 10^6 PBMCs Interval 15.0 to 62.0	41.5 ASC per 10^6 PBMCs Interval 24.0 to 73.0
IgG and IgA Antigen-Specific Antibody Secreting Cell (ASC) Mucosal Responses ASC IgG (LPS)	0.0 ASC per 10^6 PBMCs Interval 0.0 to 0.5	0.0 ASC per 10^6 PBMCs Interval 0.0 to 0.0	1.0 ASC per 10^6 PBMCs Interval 0.0 to 3.0	2.0 ASC per 10^6 PBMCs Interval 0.0 to 9.0
IgG and IgA Antigen-Specific Antibody Secreting Cell (ASC) Mucosal Responses ASC IgA (LPS)	0.0 ASC per 10^6 PBMCs Interval 0.0 to 0.0	4.0 ASC per 10^6 PBMCs Interval 1.0 to 23.0	1.0 ASC per 10^6 PBMCs Interval 0.0 to 7.0	3.0 ASC per 10^6 PBMCs Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 56 Days

ALS responses were assessed using isolated peripheral blood mononuclear cells (PBMCs). For each antigen, pre- and post-vaccination samples were tested on the same plates for total and vaccine-specific numbers. The ALS responses indirectly reflect intestinal immune responses through measurement of antigen-specific B-lymphocytes in systemic circulation before homing to gut effector sites. An ALS response was defined as a ≥ 4-fold increase over baseline ALS titers.

Outcome measures

Outcome measures
Measure	10 μg S. Flexneri 2a Invaplex n=8 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 Participants 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=9 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 Participants 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
IgG and IgA Antigen-Specific Antibody Lymphocyte Supernatant (ALS) Mucosal Responses ALS IgG (Invaplex)	1.2 fold change Interval 0.8 to 1.8	8.6 fold change Interval 2.5 to 29.7	9.3 fold change Interval 2.9 to 30.5	7.0 fold change Interval 2.8 to 17.6
IgG and IgA Antigen-Specific Antibody Lymphocyte Supernatant (ALS) Mucosal Responses ALS IgA (Invaplex)	1.3 fold change Interval 0.7 to 2.4	8.6 fold change Interval 2.4 to 30.5	3.7 fold change Interval 1.3 to 10.9	4.3 fold change Interval 1.7 to 10.7
IgG and IgA Antigen-Specific Antibody Lymphocyte Supernatant (ALS) Mucosal Responses ALS IgG (LPS)	1.2 fold change Interval 0.8 to 1.8	2.9 fold change Interval 1.4 to 6.0	4.0 fold change Interval 1.9 to 8.5	3.5 fold change Interval 1.8 to 6.7
IgG and IgA Antigen-Specific Antibody Lymphocyte Supernatant (ALS) Mucosal Responses ALS IgA (LPS)	1.1 fold change Interval 0.9 to 1.3	3.2 fold change Interval 1.5 to 6.7	2.0 fold change Interval 1.2 to 3.4	2.1 fold change Interval 1.2 to 3.9

Adverse Events

10 μg S. Flexneri 2a Invaplex

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

50 μg S. Flexneri 2a Invaplex

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

250 μg S. Flexneri 2a Invaplex

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

500 μg S. Flexneri 2a Invaplex

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Christopher Duplessis, MD

Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC)

Phone: 301-319-9047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	10 μg S. Flexneri 2a Invaplex n=9 participants at risk 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	50 μg S. Flexneri 2a Invaplex n=9 participants at risk 9 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	250 μg S. Flexneri 2a Invaplex n=10 participants at risk 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.	500 μg S. Flexneri 2a Invaplex n=10 participants at risk 10 subjects vaccinated on days 0, 14, 28 Shigella flexneri 2a InvaplexAR: The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Investigations AST Elevation	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	30.0% 3/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	77.8% 7/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	40.0% 4/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	30.0% 3/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
General disorders Fatigue	33.3% 3/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	40.0% 4/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
General disorders Fever	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Nervous system disorders Headache	33.3% 3/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	40.0% 4/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	50.0% 5/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Eye disorders Itchy Eyes	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	30.0% 3/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Burning	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	66.7% 6/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	55.6% 5/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	60.0% 6/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	100.0% 10/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Itching	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	44.4% 4/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Hyperemia	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	60.0% 6/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Pain	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Stuffiness	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Nasal Tenderness	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	30.0% 3/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	40.0% 4/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Infections and infestations Pharyngitis	33.3% 3/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	40.0% 4/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	70.0% 7/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Post-Nasal Drip	22.2% 2/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	44.4% 4/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	60.0% 6/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	90.0% 9/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary Irritation	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	44.4% 4/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	55.6% 5/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	70.0% 7/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	60.0% 6/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	33.3% 3/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Sneezing	44.4% 4/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	33.3% 3/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	50.0% 5/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	50.0% 5/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Eye disorders Tearing Eyes	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection (URI)	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Gastrointestinal disorders Abdominal Cramps	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Gastrointestinal disorders Abdominal Discomfort	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Musculoskeletal and connective tissue disorders Back Pain	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Cardiac disorders Bradycardia	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Investigations BUN Elevation	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
General disorders Chest Tightness (Unknown Etiology)	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Gastrointestinal disorders Dry Chapped Lips	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Blood and lymphatic system disorders Hemoglobinemia	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Vascular disorders Hypertension	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	11.1% 1/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Musculoskeletal and connective tissue disorders Joint Aches (Left Knee and Left Elbow)	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	10.0% 1/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/9 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	20.0% 2/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.	0.00% 0/10 • Through study completion, an average of 8 months Vaccine-related (possibly, probably, definitely) surveyed signs and symptoms of all study subjects receiving at least one dose of investigational product was assessed through targeted physical exams, symptom surveys, and other adverse events (AE) monitoring. Subjects were observed in clinic for 30 minutes, 24 hours, and 7days post vaccination to review their symptom diaries and to report any AEs. All vaccine-related and unrelated (not related, unlikely) AEs were reported.