Trial Outcomes & Findings for Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer (NCT NCT01433172)

Last Updated: 2019-08-06

Results Overview

Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10\^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10\^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

73 participants

Primary outcome timeframe

Up to 6 Months

Results posted on

2019-08-06

Participant Flow

Participants were enrolled at Moffitt Cancer Center between April 2012 and June 2015.

Three participants were enrolled in the Phase I portion of the study, followed by seventy participants enrolled in the Randomized Phase II portion of the study.

Participant milestones

Participant milestones
Measure	Phase I GM.CD40L.CCL21 Vaccinations Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.	Phase II Arm A GM.CD40L Cells Vaccinations Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.	Phase II Arm B GM.CD40L.CCL21 Vaccinations Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
Overall Study STARTED	3	37	33
Overall Study COMPLETED	3	34	32
Overall Study NOT COMPLETED	0	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II Arm A GM.CD40L Cells Vaccinations Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.	Phase II Arm B GM.CD40L.CCL21 Vaccinations Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
Overall Study Withdrawal by Subject	1	0
Overall Study Disease Progression	0	1
Overall Study Death	2	0

Baseline Characteristics

Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Vaccinations n=3 Participants Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm A Vaccinations n=37 Participants Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B Vaccinations n=33 Participants Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	46 Participants n=4 Participants
Age, Continuous	68 years n=5 Participants	62 years n=7 Participants	65 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	35 Participants n=4 Participants
Region of Enrollment United States	3 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	73 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 6 Months

Population: All Phase I Participants

Outcome measures

Outcome measures
Measure	Phase I GM.CD40L.CCL21 Vaccinations n=3 Participants Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B GM.CD40L.CCL21 Vaccinations Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
Phase I: Recommend Phase II Dose (RPDII)	1 Recommend Phase II Dose Level	—

PRIMARY outcome

Timeframe: Up to 6 Months

Population: A Phase II participants evaluable at time of analysis.

PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Phase I GM.CD40L.CCL21 Vaccinations n=33 Participants Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B GM.CD40L.CCL21 Vaccinations n=32 Participants Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
Phase II: Progression Free Survival (PFS)	2.4 months Interval 1.6 to 4.4	3.1 months Interval 1.6 to 4.4

SECONDARY outcome

Timeframe: Up to 12 Months

Population: All Phase II participants

Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline.

Outcome measures

Outcome measures
Measure	Phase I GM.CD40L.CCL21 Vaccinations n=37 Participants Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B GM.CD40L.CCL21 Vaccinations n=33 Participants Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
Response Rate Complete Response	0 Participants	0 Participants
Response Rate Partial Response	0 Participants	0 Participants
Response Rate Progressive Disease	19 Participants	20 Participants
Response Rate Stable Disease	18 Participants	12 Participants

Adverse Events

Phase I GM.CD40L.CCL21 Vaccinations

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase II Arm A GM.CD40L Vaccinations

Serious events: 14 serious events

Other events: 35 other events

Deaths: 0 deaths

Phase II Arm B GM.CD40L.CCL21 Vaccinations

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jhanelle Gray

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-3050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Phase I GM.CD40L.CCL21 Vaccinations n=3 participants at risk Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm A GM.CD40L Vaccinations n=37 participants at risk Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B GM.CD40L.CCL21 Vaccinations n=33 participants at risk Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Cardiac disorders Supraventricular tachycardia	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Gastrointestinal disorders Nausea	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Death NOS	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	15.2% 5/33 • Number of events 5 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Fatigue	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Fever	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Pain	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Infections and infestations Gallbladder infection	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Infections and infestations Lung infection	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Investigations Blood bilirubin increased	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Renal and urinary disorders Renal and urinary disorders - Other, specify	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Vascular disorders Thromboembolic event	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.

Other adverse events
Measure	Phase I GM.CD40L.CCL21 Vaccinations n=3 participants at risk Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm A GM.CD40L Vaccinations n=37 participants at risk Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.	Phase II Arm B GM.CD40L.CCL21 Vaccinations n=33 participants at risk Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
Infections and infestations Infections and infestations - Other	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Nervous system disorders Ataxia	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Injection site reaction	33.3% 1/3 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	51.4% 19/37 • Number of events 39 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	63.6% 21/33 • Number of events 45 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Fatigue	66.7% 2/3 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	51.4% 19/37 • Number of events 21 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	45.5% 15/33 • Number of events 18 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Edema limbs	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	13.5% 5/37 • Number of events 5 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	12.1% 4/33 • Number of events 4 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Pain	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	21.2% 7/33 • Number of events 8 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Fever	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	8.1% 3/37 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Flu like symptoms	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Non-cardiac chest pain	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	8.1% 3/37 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Chills	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders General disorders and administration site conditions - Other	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 4 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Gait disturbance	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
General disorders Localized edema	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	29.7% 11/37 • Number of events 14 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	39.4% 13/33 • Number of events 15 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	27.0% 10/37 • Number of events 10 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	39.4% 13/33 • Number of events 14 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	9.1% 3/33 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/37 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	16.2% 6/37 • Number of events 8 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	33.3% 11/33 • Number of events 11 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	18.9% 7/37 • Number of events 8 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	12.1% 4/33 • Number of events 6 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	8.1% 3/37 • Number of events 3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	12.1% 4/33 • Number of events 6 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	10.8% 4/37 • Number of events 5 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	5.4% 2/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	12.1% 4/33 • Number of events 4 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	6.1% 2/33 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	0.00% 0/3 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	8.1% 3/37 • Number of events 4 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	3.0% 1/33 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 2 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	2.7% 1/37 • Number of events 1 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.	0.00% 0/33 • 3 years, 8 months All Serious Adverse Events and Other (not including Serious) Adverse Events are listed, regardless of causality. All SAEs were either not related or unlikely to be related to study vaccines.