Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013) (NCT NCT01460719)

NCT ID: NCT01460719

Last Updated: 2019-03-11

Results Overview

The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10\^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at \~28 days after Vaccination 4 / GMC on Day 1.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 80 participants
• Primary outcome timeframe: Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)
• Results posted on: 2019-03-11

Participant Flow

A total of 88 participants were screened and 80 were enrolled.

Participant milestones

Measure	V212 Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Overall Study STARTED	80
Overall Study Vaccination 1 (Day 1)	80
Overall Study Vaccination 2 (~Day 30)	78
Overall Study Vaccination 3 (~Day 60)	78
Overall Study Vaccination 4 (~Day 90)	78
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	V212 Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)

Baseline characteristics by cohort

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Age, Continuous	61.0 Years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)

Population: Vaccinated participants having valid results at Baseline (Day 1) and/or at \~28 days after Vaccination 4.

The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1.

Outcome measures

Measure	V212 n=78 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)	4.34 Ratio Interval 3.01 to 6.24

PRIMARY outcome

Timeframe: Up to ~28 days after Vaccination 4 (~Day 118)

Population: All enrolled participants

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With an Adverse Event	85.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 5 days after any vaccination

Population: All enrolled participants

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With an Injection-site Adverse Event	43.8 Percentage of participants

PRIMARY outcome

Timeframe: Up to ~28 days after Vaccination 4 (~Day 118)

Population: All enrolled participants

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With a Systemic Adverse Event	73.8 Percentage of participants

PRIMARY outcome

Timeframe: Up to ~28 days after Vaccination 4 (~Day 118)

Population: All enrolled participants

A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With a Serious Adverse Event	15.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to ~28 days after Vaccination 4 (~Day 118)

Population: All enrolled participants

A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With a Vaccine-related Serious Adverse Event	1.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to Vaccination 4 (~Day 90)

Population: All enrolled participants

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.

Outcome measures

Measure	V212 n=80 Participants Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event	1.3 Percentage of participants

Adverse Events

V212

Serious events: 12 serious events

Other events: 67 other events

Deaths: 1 deaths

Serious adverse events

Measure	V212 n=80 participants at risk Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Blood and lymphatic system disorders Febrile neutropenia	5.0% 4/80 • Number of events 4 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Neutropenia	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Diarrhoea	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Nausea	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Pyrexia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Candidiasis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Pneumonia	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Salmonellosis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Injury, poisoning and procedural complications Subdural haematoma	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma stage 0	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Convulsion	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212

Other adverse events

Measure	V212 n=80 participants at risk Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose
Infections and infestations Cystitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Ear infection	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Folliculitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Localised infection	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Nasopharyngitis	3.8% 3/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Oral candidiasis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Oral herpes	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Pneumonia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Rhinitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Sinusitis	3.8% 3/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Trichophytosis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Upper respiratory tract infection	3.8% 3/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Urinary tract infection	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Viral tracheitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Vulvovaginal candidiasis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Vulvovaginal mycotic infection	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Injury, poisoning and procedural complications Arthropod bite	7.5% 6/80 • Number of events 10 • Up to Day 140 All participants who received at least one dose of V212
Injury, poisoning and procedural complications Excoriation	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Injury, poisoning and procedural complications Laceration	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Injury, poisoning and procedural complications Post-traumatic pain	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Investigations Weight decreased	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Metabolism and nutrition disorders Decreased appetite	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Metabolism and nutrition disorders Dehydration	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Metabolism and nutrition disorders Hypercholesterolaemia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Metabolism and nutrition disorders Hyperuricaemia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 3/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Back pain	5.0% 4/80 • Number of events 5 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Bone pain	3.8% 3/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Bursitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Jaw disorder	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Myalgia	5.0% 4/80 • Number of events 7 • Up to Day 140 All participants who received at least one dose of V212
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 2/80 • Number of events 4 • Up to Day 140 All participants who received at least one dose of V212
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Carotid artery stenosis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Dizziness	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Headache	8.8% 7/80 • Number of events 9 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Hypoaesthesia	2.5% 2/80 • Number of events 3 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Migraine	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Motor dysfunction	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Neuropathy peripheral	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Paraesthesia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Peripheral motor neuropathy	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Nervous system disorders Peripheral sensory neuropathy	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Psychiatric disorders Hallucination, auditory	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Psychiatric disorders Insomnia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Cough	7.5% 6/80 • Number of events 6 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.5% 6/80 • Number of events 8 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Productive cough	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Ecchymosis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Pain of skin	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Papule	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Pruritus	3.8% 3/80 • Number of events 5 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Rash	7.5% 6/80 • Number of events 7 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Rash pruritic	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Rash vesicular	6.2% 5/80 • Number of events 5 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Rosacea	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Skin burning sensation	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Skin discolouration	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Skin and subcutaneous tissue disorders Skin lesion	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Vascular disorders Peripheral coldness	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Anaemia	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Leukocytosis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Lymphadenopathy	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Neutropenia	7.5% 6/80 • Number of events 7 • Up to Day 140 All participants who received at least one dose of V212
Blood and lymphatic system disorders Pancytopenia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Ear and labyrinth disorders Ear pain	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Ear and labyrinth disorders Vertigo	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Eye disorders Conjunctivitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Abdominal distension	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Abdominal pain	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Abdominal pain upper	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Aphthous stomatitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Diarrhoea	12.5% 10/80 • Number of events 13 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Dyspepsia	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Gastric ulcer	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Gastrointestinal disorder	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Glossodynia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Lip blister	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Nausea	5.0% 4/80 • Number of events 5 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Pancreatitis acute	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Rectal haemorrhage	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Stomatitis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Gastrointestinal disorders Toothache	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Chest pain	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Chills	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Fatigue	5.0% 4/80 • Number of events 5 • Up to Day 140 All participants who received at least one dose of V212
General disorders Feeling hot	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site erythema	31.2% 25/80 • Number of events 54 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site haematoma	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site movement impairment	1.2% 1/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site pain	32.5% 26/80 • Number of events 57 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site paraesthesia	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site pruritus	6.2% 5/80 • Number of events 9 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site rash	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Injection site swelling	26.2% 21/80 • Number of events 49 • Up to Day 140 All participants who received at least one dose of V212
General disorders Malaise	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Mucosal dryness	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Oedema peripheral	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212
General disorders Pain	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
General disorders Pyrexia	25.0% 20/80 • Number of events 27 • Up to Day 140 All participants who received at least one dose of V212
General disorders Spinal pain	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Hepatobiliary disorders Hepatic cyst	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Acariasis	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Anal abscess	1.2% 1/80 • Number of events 1 • Up to Day 140 All participants who received at least one dose of V212
Infections and infestations Bronchitis	2.5% 2/80 • Number of events 2 • Up to Day 140 All participants who received at least one dose of V212

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER