Trial Outcomes & Findings for COVID-19 Vaccination of Immunodeficient Persons (COVAXID) (NCT NCT04780659)

NCT ID: NCT04780659

Last Updated: 2025-12-04

Results Overview

Proportion (95% confidence interval, CI) seroconverting to positive response to SARS-CoV-2 IgG serology test after two doses of vaccine, measured 2 weeks after second dose of vaccine.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 539 participants
• Primary outcome timeframe: 2 weeks after second dose of vaccine.
• Results posted on: 2025-12-04

Participant Flow

Recruitment of the primary study population (immunosuppressed participants ) took place at Karolinska University Hospital. The control group was recruited, for example, from among staff at Karolinska University Hospital and, if necessary, from other healthcare units or facilities, such as primary care centers, via the Always Open app, recruitment flyers, or advertisements.

781 participants were screened for the study at at Karolinska University Hospital between February 12th and 22nd, 2021 and 539 were included and recived the first vaccin dose. The main reasons for screening failure were previous COVID-19 infection, patient refusal, and that some study subjects already had been vaccinated outside the study.

Participant milestones

Measure	All Immunocompromised Patients This arm consists of individuals with a primary immunodeficiency disorder.	Controls The control group consisted of individuals without a primary immunodeficiency disorder.
Overall Study STARTED	449	90
Overall Study COMPLETED	439	90
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Measure	All Immunocompromised Patients This arm consists of individuals with a primary immunodeficiency disorder.	Controls The control group consisted of individuals without a primary immunodeficiency disorder.
Overall Study Adverse event, serious fatal	3	0
Overall Study Withdrawal by Subject	3	0
Overall Study Physician Decision	1	0
Overall Study Died in original disease	2	0
Overall Study Leukemia relapse (more than 6 weeks after dose 2)	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Immunocompromised Patients n=449 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=90 Participants The control group consisted of individuals without a primary immunodeficiency disorder.	Total n=539 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=449 Participants	0 Participants n=90 Participants	0 Participants n=539 Participants
Age, Categorical Between 18 and 65 years	181 Participants n=449 Participants	27 Participants n=90 Participants	208 Participants n=539 Participants
Age, Categorical >=65 years	268 Participants n=449 Participants	63 Participants n=90 Participants	331 Participants n=539 Participants
Sex: Female, Male Female	242 Participants n=449 Participants	51 Participants n=90 Participants	293 Participants n=539 Participants
Sex: Female, Male Male	207 Participants n=449 Participants	39 Participants n=90 Participants	246 Participants n=539 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	449 participants n=449 Participants	90 participants n=90 Participants	539 participants n=539 Participants
Ongoing immunosuppression at baseline Corticosteroids	26 Participants n=449 Participants	0 Participants n=90 Participants	26 Participants n=539 Participants
Ongoing immunosuppression at baseline Other immunosuppressive agents	159 Participants n=449 Participants	0 Participants n=90 Participants	159 Participants n=539 Participants
Ongoing immunosuppression at baseline No ongoing immunosuppression at baseline	264 Participants n=449 Participants	90 Participants n=90 Participants	354 Participants n=539 Participants
Immunogloublin G (IgG) level at baseline	9.9 Immunglobulin G, IgG (g/L) n=449 Participants	11.0 Immunglobulin G, IgG (g/L) n=90 Participants	10.1 Immunglobulin G, IgG (g/L) n=539 Participants
Absolute lymphocyte count(10^9 cells/L) at baseline	1.6 Absolute lymphocyte count (10^9 cells/L) n=449 Participants	1.8 Absolute lymphocyte count (10^9 cells/L) n=90 Participants	1.6 Absolute lymphocyte count (10^9 cells/L) n=539 Participants

PRIMARY outcome

Timeframe: 2 weeks after second dose of vaccine.

Proportion (95% confidence interval, CI) seroconverting to positive response to SARS-CoV-2 IgG serology test after two doses of vaccine, measured 2 weeks after second dose of vaccine.

Outcome measures

Measure	All Immunocompromised Patients n=388 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=78 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Assessment of Seroconversion, Defined as Development of Immunoglobulin G (IgG) Antibodies Against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) After Vaccination of 2 Doses in Seronegative Individuals. Seroconverted	280 Participants	78 Participants
Assessment of Seroconversion, Defined as Development of Immunoglobulin G (IgG) Antibodies Against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) After Vaccination of 2 Doses in Seronegative Individuals. Seronegative	108 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of 0-14 days after the first vaccine dose.

Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 1)

Outcome measures

Measure	All Immunocompromised Patients n=449 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=90 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Assessment of Any Adverse Events (AE) of the Given Vaccine. AE	94 Participants	6 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. SAE	10 Participants	0 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. SUSAR	1 Participants	0 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. No AE/SAE/SUSAR	344 Participants	84 Participants

SECONDARY outcome

Timeframe: Duration of 0-14 days after the second vaccine dose.

Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 2)

Outcome measures

Measure	All Immunocompromised Patients n=446 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=88 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Assessment of Any Adverse Events (AE) of the Given Vaccine. AE	87 Participants	5 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. SAE	13 Participants	0 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. SUSAR	0 Participants	0 Participants
Assessment of Any Adverse Events (AE) of the Given Vaccine. No AE/SAE/SUSAR	346 Participants	83 Participants

SECONDARY outcome

Timeframe: After the first vaccin dose

Number and proportion (95% CI) who experience local and systemic reactions (after dose 1)

Outcome measures

Measure	All Immunocompromised Patients n=444 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=89 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Frequency Who Experience Local and Systemic Reactions No reaction	66 Participants	18 Participants
Frequency Who Experience Local and Systemic Reactions Any reaction (grade 1 - 4)	378 Participants	71 Participants

SECONDARY outcome

Timeframe: After the second vaccin dose

Number and proportion (95% CI) who experience local and systemic reactions (after dose 2)

Outcome measures

Measure	All Immunocompromised Patients n=422 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=87 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Frequency Who Experience Local and Systemic Reactions Any reaction (grade 1 - 4)	337 Participants	74 Participants
Frequency Who Experience Local and Systemic Reactions No reaction	85 Participants	13 Participants

SECONDARY outcome

Timeframe: 0 - 6 months

Proportion (95% CI) diagnosed with a new SARS-CoV-2 infection confirmed by a positive PCR test

Outcome measures

Measure	All Immunocompromised Patients n=388 Participants This arm consists of individuals with a primary immunodeficiency disorder.	Controls n=78 Participants The control group consisted of individuals without a primary immunodeficiency disorder.
Frequency of SARS-CoV-2 Infection Documented by PCR Test. No	370 Participants	76 Participants
Frequency of SARS-CoV-2 Infection Documented by PCR Test. Yes	18 Participants	2 Participants

Adverse Events

All Immunocompromised Patients

Serious events: 23 serious events

Other events: 173 other events

Deaths: 5 deaths

Controls

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Immunocompromised Patients n=449 participants at risk This arm consisted of individuals with a primary immunodeficiency disorder.	Controls n=90 participants at risk The control group consisted of individuals without a primary immunodeficiency disorder.
Investigations Increased CRP	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Cardiac disorders Myocardial infarction	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Cardiac disorders Atrial fibrillation	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Cardiac disorders Heart failure	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Surgical and medical procedures Surgery for colon carcinoma	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Syncope	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Organ rejection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Ileus	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Pancreatitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Abdominal pain	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Hepatobiliary disorders Alanine aminotransferase increase/aspartate aminotransferase increase	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.22% 1/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Renal and urinary disorders Urinary tract obstruction	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Back pain	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations COVID-19	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Bone infection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Urinary tract infection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Sepsis	0.45% 2/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Sinusitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Catheter related infection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Metabolism and nutrition disorders Dehydration	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Metabolism and nutrition disorders Hyperglycemia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.

Other adverse events

Measure	All Immunocompromised Patients n=449 participants at risk This arm consisted of individuals with a primary immunodeficiency disorder.	Controls n=90 participants at risk The control group consisted of individuals without a primary immunodeficiency disorder.
Vascular disorders Hypertension	2.9% 13/449 • Number of events 13 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Vascular disorders Superficial thrombophlebitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Vascular disorders Hematoma	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Surgical and medical procedures Lymph node punction	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Increase thirst	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Localized edema	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Injection site reaction	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Flu like symptoms	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Fever	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Vaccination site lymphadenopathy	1.3% 6/449 • Number of events 6 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Chest pain	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
General disorders Fatigue	2.2% 10/449 • Number of events 10 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	3.3% 3/90 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Reproductive system and breast disorders Vaginal dryness	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Unpleasantness while breathing	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Tachypnea	1.3% 6/449 • Number of events 6 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Development of bronchiolitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Respiratory, thoracic and mediastinal disorders Cough	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Psychiatric disorders Insomnia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Psychiatric disorders Nightmares	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Lymphocyte count decreased	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Cholesterol high	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Leukopenia	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Platelet count decreased	3.8% 17/449 • Number of events 17 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Pancytopenia	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Monocyte count increased	1.3% 6/449 • Number of events 6 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Neutrophil count deceased	1.1% 5/449 • Number of events 5 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Increased lymphocyte count	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Creatinine increased	3.8% 17/449 • Number of events 17 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	2.2% 2/90 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Investigations Blood bilirubin increased	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Cardiac disorders Tachycardia	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Vasovagal reaction	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Migraine	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Headache	1.3% 6/449 • Number of events 6 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Memory impairment	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Nervous system disorders Dizziness	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Blood and lymphatic system disorders Increased neutrophil count	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Blood and lymphatic system disorders Leukocytosis	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Blood and lymphatic system disorders Anemia	1.6% 7/449 • Number of events 7 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Ear and labyrinth disorders External otitis	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Ear and labyrinth disorders Tinnitus	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Rectal hemorrhage	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Gastritis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Dysphagia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Dry mouth	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Diarrhea	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Abdominal pain	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Vomiting	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Gastrointestinal disorders Mucositis	0.89% 4/449 • Number of events 5 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Hepatobiliary disorders Increased LFTs	2.0% 9/449 • Number of events 9 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Hepatobiliary disorders Increased AST/ALT	2.4% 11/449 • Number of events 11 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Skin and subcutaneous tissue disorders Pruritus	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Skin and subcutaneous tissue disorders Skin rash	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Skin and subcutaneous tissue disorders Skin ulceration	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Skin and subcutaneous tissue disorders GVHD	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Endocrine disorders Enlarged thyroid gland	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Pain in extremity	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Neck pain	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Myalgia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Muscle cramp	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Traumatic knee injury	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Tendititis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Back pain	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Musculoskeletal and connective tissue disorders Arthralgia	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	1.1% 1/90 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Covid-19	0.89% 4/449 • Number of events 4 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	2.2% 2/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Shingles	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations BK-viremia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Bronchiolitis obliterans	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Conjunctivitis	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Bacterial infection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Urinary tract infection	1.3% 6/449 • Number of events 6 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Upper respiratory infection	4.7% 21/449 • Number of events 22 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Sinusitis	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Strongyloides infection	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Bacterial infection UNS	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Herpes simplex reactivation	0.67% 3/449 • Number of events 3 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Infections and infestations Cytomegalovirus infection reactivation	0.45% 2/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Metabolism and nutrition disorders Hypercalcemia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Metabolism and nutrition disorders Hyperuricemia	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Metabolism and nutrition disorders Hyperglycemia	0.22% 1/449 • Number of events 2 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Reproductive system and breast disorders Breast pain	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Psychiatric disorders Confusion	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.
Eye disorders GVHD in eye	0.22% 1/449 • Number of events 1 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.	0.00% 0/90 • Adverse events (AEs) were recorded from the time of inclusion until visit 4, which occurred two weeks after administration of the second vaccine dose. Serious Adverse events (SAE) were documented up to visit 5, six weeks after the second vaccine dose. All Adverse Events (AE) were documented, exceptions included medical events that were anticipated sequelae of the underlying condition, such as exacerbation of the primary disease.

Additional Information

Soo Aleman Sponsor representative

Karolinska University Hospital

Phone: +46 72595 7225

Email: soo.aleman@regionstockholm.se

Results disclosure agreements

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