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| ID | Type | Description | Link |
|---|---|---|---|
| V212-004 | Other Identifier | Merck |
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The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine | Experimental | Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered ~30 days apart. |
|
| Part 1: Gamma- Irradiated VZV Vaccine A | Experimental | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart. |
|
| Part 1: Placebo | Placebo Comparator | Participants received a 4-dose placebo regimen administered ~30 days apart. |
|
| Part 2: Gamma- Irradiated VZV Vaccine B | Experimental | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart. |
|
| Part 2: Gamma- Irradiated VZV Vaccine C | Experimental | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: V212 | Biological | 0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients | Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome. | Baseline and ~28 days Postdose 4 (~Day 118) |
| Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and ~28 days Postdose 4 (~Day 118) |
| Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and ~28 days Postdose 4 (~Day 118) |
| Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed. | Up to ~28 days Postdose 4 (Up to ~118 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA | Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and ~28 days Postdose 4 (~Day 118) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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In Part 1, all participants received heat-treated varicella zoster virus (VZV) vaccine, gamma-irradiated VZV vaccine A or placebo administered as a 4-dose regimen approximately every 30 days. In Part 2, all participants received either gamma-irradiated VZV vaccine B or C administered as a 4-dose regimen approximately every 30 days.
The study was performed in 2 parts - Part 1 and Part 2, with a total of 160 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine | Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered ~30 days apart. |
| FG001 | Part 1: Gamma-Irradiated VZV Vaccine A | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart. |
| FG002 | Part 1: Placebo | Participants received a 4-dose placebo regimen administered ~30 days apart. |
| FG003 | Part 2: Gamma-Irradiated VZV Vaccine B | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart. |
| FG004 | Part 2: Gamma-Irradiated VZV Vaccine C | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine | Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered ~30 days apart. |
| BG001 | Part 1: Gamma-Irradiated VZV Vaccine A |
| 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 | Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients | Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome. | The analysis population included all gamma-irradiated VZV vaccine A participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine B, vaccine C and placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days Postdose 4 (~Day 118) |
|
Up to ~28 days Postdose 4 (up to ~118 days)
All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
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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 | Part 1 Heat-treated VZV Vaccine | Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Comparator: Placebo | Biological | Placebo; 4-dose regimen administered ~30 days apart. |
|
| Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card |
An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups. |
| Up to Day 5 post any vaccination (Up to ~5 days) |
| Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card | 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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups. | Up to ~28 days Postdose 4 (Up to ~118 days) |
| Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card | Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed. | Up to ~28 days Postdose 4 (Up to ~118 days) |
| Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event | An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed. | Up to Dose 4 (Up to ~90 days) |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Adverse Event |
|
Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart. |
| BG002 | Part 1: Placebo | Participants received a 4-dose placebo regimen administered ~30 days apart. |
| BG003 | Part 2: Gamma-Irradiated VZV Vaccine B | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart. |
| BG004 | Part 2: Gamma-Irradiated VZV Vaccine C | Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Part 1: Gamma- Irradiated VZV Vaccine A |
Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart. |
|
|
|
| Primary | Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | The analysis population included all gamma-irradiated VZV vaccine B participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine C and placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days Postdose 4 (~Day 118) |
|
|
|
|
| Primary | Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | The analysis population included all gamma-irradiated VZV vaccine C participants who received all 4 vaccinations and had no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine B and placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days Postdose 4 (~Day 118) |
|
|
|
|
| Secondary | Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA | Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | The analysis population included all heat-treated VZV vaccine participants who received all 4 vaccinations and had no protocol deviations; vaccine A, vaccine B, vaccine C and placebo participants were not assessed for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and ~28 days Postdose 4 (~Day 118) |
|
|
|
|
| Primary | Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed. | The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination. | Posted | Number | Percentage of Participants | Up to ~28 days Postdose 4 (Up to ~118 days) |
|
|
|
|
| Primary | Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card | An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups. | The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination. | Posted | Number | Percentage of Participants | Up to Day 5 post any vaccination (Up to ~5 days) |
|
|
|
|
| Primary | Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card | 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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups. | The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination. | Posted | Number | Percentage of Participants | Up to ~28 days Postdose 4 (Up to ~118 days) |
|
|
|
|
| Primary | Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card | Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed. | The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination. | Posted | Number | Percentage of Participants | Up to ~28 days Postdose 4 (Up to ~118 days) |
|
|
|
|
| Primary | Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event | An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed. | The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination. | Posted | Number | Percentage of Participants | Up to Dose 4 (Up to ~90 days) |
|
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 47 |
| 64 |
| EG001 | Gamma-irradiated VZV Vaccine A | Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart. | 0 | 61 | 1 | 61 | 48 | 61 |
| EG002 | Placebo | Participants received a 4-dose placebo regimen administered ~30 days apart. | 0 | 32 | 0 | 32 | 20 | 32 |
| EG003 | Part 2 Gamma-irradiated VZV Vaccine B | Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart. | 0 | 63 | 1 | 63 | 47 | 63 |
| EG004 | Gamma-irradiated VZV Vaccine C | Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart. | 0 | 65 | 0 | 65 | 43 | 65 |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eye allergy | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Scleral disorder | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site papule | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bed bug infestation | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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. SPONSOR review can be expedited to meet publication guidelines.
| D007239 | Infections |
| Difference in Percentage |
| 1.6 |
| 2-Sided |
| 95 |
| -9.2 |
| 8.8 |
Miettinen & Nurminen |
| Other |
| Difference in Percentage |
| 40.4 |
| 2-Sided |
| 95 |
| 19.6 |
| 57.0 |
| Other |
| Difference in Percentage |
| 4.1 |
| 2-Sided |
| 95 |
| -16.9 |
| 24.9 |
Miettinen & Nurminen |
| Other |
| Difference in Percentage |
| 1.6 |
| 2-Sided |
| 95 |
| -9.2 |
| 8.8 |
| Other |
| Difference in Percentage |
| 0.0 |
| 2-Sided |
| 95 |
| -10.8 |
| 6.0 |
Miettinen & Nurminen |
| Other |