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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 05-0128 | |||
| EudraCT No. 2005-001781-14 |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo.
The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP 1: two x 1x10E08 TCID, MVA-BN® s.c., vaccinia naive | Experimental | vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID) |
|
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., vaccinia naive | Experimental | vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer) |
|
| GP 3: two x Placebo, s.c., vaccinia naive | Placebo Comparator | vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer). |
|
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., vaccinia experienced | Experimental | vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-BN® (IMVAMUNE) | Biological | 1x 10E8_TCID50 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) |
| Number of Participants With ECG Changes | Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6). | within 2 weeks after each vaccination |
| Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Occurrence and relationship of any other cardiac symptom at any time during the study | within 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. |
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Inclusion Criteria:
Groups 1, 2 and 3 (All vaccinia-naïve subjects) additionally:
Group 4 (All previously vaccinated subjects) additionally:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank von Sonnenburg, Prof | Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrison Clinical Research GmbH | Munich | Bavaria | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25879867 | Result | Zitzmann-Roth EM, von Sonnenburg F, de la Motte S, Arndtz-Wiedemann N, von Krempelhuber A, Uebler N, Vollmar J, Virgin G, Chaplin P. Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population. PLoS One. 2015 Apr 16;10(4):e0122653. doi: 10.1371/journal.pone.0122653. eCollection 2015. | |
| 36408618 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 2 x MVA-BN® s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) |
| FG001 | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer) |
| FG002 | Group 3: Two x Placebo, s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer). Placebo: Tris-Buffer |
| FG003 | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID50). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Dataset
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 2x MVA-BN® s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutaneous vaccinations with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) |
| BG001 | Group 2: 1x MVA-BN®, 1x Placebo, s.c., Vaccinia Naive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Seroconversion by ELISA | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of subjects | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) |
|
32 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GP 1: Two x 1x10E08 TCID, MVA-BN® s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID) MVA-BN® (IMVAMUNE): 1x 10E8_TCID50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sarcoidosis | Immune system disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Lead, Clinical Operations | Bavarian Nordic A/S | +45 3326 | 8383 | info@bavarian-nordic.com |
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| ID | Term |
|---|---|
| D012899 | Smallpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
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| Placebo | Biological | Tris-Buffer |
|
| 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4) |
| Percentage of Participants With Seroconversion by PRNT | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) |
| Percentage of Participants With Seroconversion by PRNT | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4) |
| Number of Participants With Related Serious Adverse Events | Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study | within 32 weeks |
| Number of Participants With Solicited Local Adverse Events | Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. | within 8 days after any vaccination |
| Number of Participants With Solicited General Adverse Events | Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. | within 8 days after any vaccination |
| Number of Participants With Related Grade>=3 Adverse Events | Number of participants with any Grade >=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs. | within 4 weeks after any vaccination |
| Number of Participants With Unsolicited Non-serious Adverse Events | Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). | within 4 weeks after any vaccination |
| Ilchmann H, Samy N, Reichhardt D, Schmidt D, Powell JD, Meyer TPH, Silbernagl G, Nichols R, Weidenthaler H, De Moerlooze L, Chen L, Chaplin P. One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. J Infect Dis. 2023 May 12;227(10):1203-1213. doi: 10.1093/infdis/jiac455. |
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50), followed by one vaccination Placebo (0.5mL Tris Buffer)
| BG002 | Group 3: 2x Placebo, s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5mL Tris Buffer) Placebo: Tris-Buffer |
| BG003 | Group 4: 1x MVA-BN®, s.c., Vaccinia Experienced | vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5mL MVA-BN® IMVAMUNE (1x10E08 TCID50) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive |
vaccinia naive subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID), followed by one subcutaneous vaccination Placebo (0.5ml Tris Buffer) MVA-BN® (IMVAMUNE): 1x 10E8_TCID50 Placebo: Tris-Buffer |
| OG002 | GP 3: Two x Placebo, s.c., Vaccinia Naive | vaccinia naive subjects receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer) Placebo: Tris-Buffer |
| OG003 | GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | vaccinia experienced subjects receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID) MVA-BN® (IMVAMUNE): 1x 10E8_TCID50 |
|
|
|
| Primary | Number of Participants With ECG Changes | Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6). | Safety dataset | Posted | Number | participants | within 2 weeks after each vaccination |
|
|
|
| Primary | Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI]) | Occurrence and relationship of any other cardiac symptom at any time during the study | Safety dataset | Posted | Number | events | within 32 weeks |
|
|
|
| Secondary | Percentage of Participants With Seroconversion by ELISA | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination) | Posted | Number | percentage of subjects | 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4) |
|
|
|
| Secondary | Percentage of Participants With Seroconversion by PRNT | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Full Analysis Set | Posted | Number | percentage of subjects | 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4) |
|
|
|
| Secondary | Percentage of Participants With Seroconversion by PRNT | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination) | Posted | Number | percentage of subjects | 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4) |
|
|
|
| Secondary | Number of Participants With Related Serious Adverse Events | Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study | Safety dataset | Posted | Count of Participants | Participants | within 32 weeks |
|
|
|
| Secondary | Number of Participants With Solicited Local Adverse Events | Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. | Safety dataset | Posted | Count of Participants | Participants | within 8 days after any vaccination |
|
|
|
| Secondary | Number of Participants With Solicited General Adverse Events | Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card. | Safety dataset | Posted | Count of Participants | Participants | within 8 days after any vaccination |
|
|
|
| Secondary | Number of Participants With Related Grade>=3 Adverse Events | Number of participants with any Grade >=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs. | Safety dataset | Posted | Count of Participants | Participants | within 4 weeks after any vaccination |
|
|
|
| Secondary | Number of Participants With Unsolicited Non-serious Adverse Events | Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). | Safety dataset | Posted | Count of Participants | Participants | within 4 weeks after any vaccination |
|
|
|
| 0 |
| 183 |
| 3 |
| 183 |
| 91 |
| 183 |
| EG001 | GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., Vaccinia Naive | vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer) MVA-BN® (IMVAMUNE): 1x 10E8_TCID50 Placebo: Tris-Buffer | 0 | 181 | 3 | 181 | 88 | 181 |
| EG002 | GP 3: Two x Placebo, s.c., Vaccinia Naive | vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer). Placebo: Tris-Buffer | 0 | 181 | 5 | 181 | 54 | 181 |
| EG003 | GP 4: 1x10E08 TCID, MVA-BN®, s.c., Vaccinia Experienced | vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID). MVA-BN® (IMVAMUNE): 1x 10E8_TCID50 | 0 | 200 | 1 | 200 | 73 | 200 |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA 7.1 | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA 7.1 | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA 7.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site hematoma | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site discoloration | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Lymphadenopaty | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Tonsilitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
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| SCR : Ventricular arrhythmia |
|
| SCR : AV block (PQ time >0.20 sec) 1st degree |
|
| SCR : Right bundle branch block - incomplete |
|
| SCR : ST elevation |
|
| SCR : ST depression |
|
| SCR : T inversion - pathological |
|
| SCR : T inversion - other |
|
| SCR : Low voltage |
|
| SCR : Other non-specific changes |
|
| SCR : Bradycardia |
|
| SCR : Arrhythmia |
|
| SCR : Repolarisation |
|
| SCR : Q-Abnormalities |
|
| SCR : Tall T-waves |
|
| Week 2 : Supraventricular arrhytmia |
|
| Week 2 : Ventricular arrhythmia |
|
| Week 2 : AV block (PQ time >0.20 sec) 1st degree |
|
| Week 2 : Right bundle branch block - incomplete |
|
| Week 2 : ST elevation |
|
| Week 2 : ST depression |
|
| Week 2 : T inversion - pathological |
|
| Week 2 : T inversion - other |
|
| Week 2 : Low voltage |
|
| Week 2 : Other non-specific changes |
|
| Week 2 : Bradycardia |
|
| Week 2 : Arrhythmia |
|
| Week 2 : Repolarisation |
|
| Week 2 : Q-Abnormalities |
|
| Week 2 : Tall T-waves |
|
| Week 6 : Supraventricular arrhytmia |
|
| Week 6 : Ventricular arrhythmia |
|
| Week 6 : AV block (PQ time >0.20 sec) 1st degree |
|
| Week 6 : Right bundle branch block - incomplete |
|
| Week 6 : ST elevation |
|
| Week 6 : ST depression |
|
| Week 6 : T inversion - pathological |
|
| Week 6 : T inversion - other |
|
| Week 6 : Low voltage |
|
| Week 6 : Other non-specific changes |
|
| Week 6 : Bradycardia |
|
| Week 6 : Arrhythmia |
|
| Week 6 : Repolarisation |
|
| Week 6 : Q-Abnormalities |
|
| Week 6 : Tall T-waves |
|
| Sinus tachycardia : unrelated |
|
| Tachycardia : related |
|
| Tachycardia : unrelated |
|
| Palpitations : related |
|
| Palpitations : unrelated |
|
| Mild pericardial effusion : related |
|
| Mild pericardial effusion : unrelated |
|
| Injection site erythema |
|
| Injection site swelling |
|
| Injection site induration |
|
| Headache |
|
| Myalgia |
|
| Nausea |
|
| Fatigue |
|