Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BARDA HHS010020160029C | Other Grant/Funding Number | Biomedical Advanced Research & Development Authority (BARDA) |
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
Not provided
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This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1893 | Experimental |
| |
| Placebo | Placebo Comparator | 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1893 | Biological | Zika vaccine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | Up to Day 7 after first vaccination (up to 8 days) |
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | Up to Day 7 after second vaccination (Day 29 to Day 36) |
| Number of Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Day 1, 29, 57, Month 7 and 13 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridan Clinical Research | Omaha | Nebraska | 68134 | United States | ||
| Benchmark Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36682364 | Derived | Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29. |
| FG001 | mRNA-1893 10 mcg | Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29. |
| FG002 | mRNA-1893 30 mcg | Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29. |
| FG003 | mRNA-1893 100 mcg | Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29. |
| FG004 | mRNA-1893 250 mcg | Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29. |
| BG001 | mRNA-1893 10 mcg | Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | The First Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the first study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories. | Posted | Count of Participants | Participants | Up to Day 7 after first vaccination (up to 8 days) |
Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna Clinical Trials Support Center | ModernaTX, Inc | 1-877-777-7187 | clinicaltrials@modernatx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2020 | Dec 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2021 | Dec 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2019 | Dec 22, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
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Not provided
Observer blind
| Other |
0.9% sodium chloride |
|
| Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Day 1 to the end of study visit (up to Day 392) |
| Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) |
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. |
| Day 1, 29, 57, Month 7 and 13 |
| Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Day 1, 29, 57, Month 7 and 13 |
| Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13. |
| Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Day 29, Day 57, Month 7, and Month 13 |
| Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Day 29, Day 57, Month 7, and Month 13 |
| Austin |
| Texas |
| 78705 |
| United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| Ponce School of Medicine - CAIMED Center | Ponce | 00716 | Puerto Rico |
| BG002 | mRNA-1893 30 mcg | Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29. |
| BG003 | mRNA-1893 100 mcg | Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29. |
| BG004 | mRNA-1893 250 mcg | Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Flavivirus Serostatus | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29. |
| OG001 | mRNA-1893 10 mcg | Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29. |
| OG002 | mRNA-1893 30 mcg | Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29. |
| OG003 | mRNA-1893 100 mcg | Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29. |
| OG004 | mRNA-1893 250 mcg | Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29. |
|
|
| Primary | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | The Second Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the second study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories. | Posted | Count of Participants | Participants | Up to Day 7 after second vaccination (Day 29 to Day 36) |
|
|
|
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). | Posted | Count of Participants | Participants | Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57) |
|
|
|
| Primary | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). | Posted | Count of Participants | Participants | Day 1 to the end of study visit (up to Day 392) |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, number analyzed signifies those participants were evaluable at specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1, 29, 57, Month 7 and 13 |
|
|
|
| Secondary | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1, 29, 57, Month 7 and 13 |
|
|
|
| Secondary | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1, 29, 57, Month 7 and 13 |
|
|
|
| Secondary | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. | Posted | Number | percentage of participants | Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13. |
|
|
|
| Secondary | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points. | Posted | Count of Participants | Participants | Day 29, Day 57, Month 7, and Month 13 |
|
|
|
| Secondary | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. | Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, Number of participants analyzed signifies those participants who were evaluable for this endpoint. | Posted | Count of Participants | Participants | Day 29, Day 57, Month 7, and Month 13 |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| 17 |
| 24 |
| EG001 | mRNA-1893 10 mcg | Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29. | 0 | 24 | 0 | 24 | 21 | 24 |
| EG002 | mRNA-1893 30 mcg | Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29. | 0 | 24 | 0 | 24 | 21 | 24 |
| EG003 | mRNA-1893 100 mcg | Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29. | 0 | 24 | 0 | 24 | 22 | 24 |
| EG004 | mRNA-1893 250 mcg | Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29. | 0 | 24 | 1 | 24 | 20 | 24 |
| Diverticulitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Infected bite | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Mycoplasma infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Otosalpingitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Nipple infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Trichomoniasis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v24.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA v24.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v24.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v24.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA v24.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v24.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA v24.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
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| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA v24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v24.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA v24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v24.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Infusion site rash | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA v24.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA v24.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
|
|
|
|
|
|
|
|
|
|
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| Local ARs- Pain |
|
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| Local ARs- Swelling (Hardness) |
|
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| Systemic ARs- Arthralgia |
|
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| Systemic ARs- Chills |
|
|
| Systemic ARs- Fatigue |
|
|
| Systemic ARs- Fever |
|
|
| Systemic ARs- Headache |
|
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| Systemic ARs- Myalgia |
|
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| Systemic ARs- Nausea |
|
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| Systemic ARs- Rash |
|
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| AESI |
|
|
| Day 29 |
|
|
| Day 57 |
|
|
| Month 7 |
|
|
| Month 13 |
|
|
|
| Day 29 |
|
|
| Day 57 |
|
|
| Month 7 |
|
|
| Month 13 |
|
|
|
| Day 29 |
|
|
| Day 57 |
|
|
| Month 7 |
|
|
| Month 13 |
|
|
| Day 1 to Day 57 |
|
| Day 1 to Month 7 |
|
| Day 1 to Month 13 |
|
| Day 57 |
|
| Month 7 |
|
| Month 13 |
|
| Day 29: >= 4-fold increase |
|
| Day 57: >= 2-fold increase |
|
| Day 57: >= 4-fold increase |
|
| Month 7: >= 2-fold increase |
|
| Month 7: >= 4-fold increase |
|
| Month 13: >= 2-fold increase |
|
| Month 13: >= 4-fold increase |
|