Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
NCT ID:
NCT04801420
Description:
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
Frequency Threshold:
5
Time Frame:
Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Study:
NCT04801420
Study Brief:
Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 2: VLA15 + Placebo | Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase. | 0 | None | 2 | 187 | 179 | 187 | View |
| Group 1: VLA15 | Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase. | 0 | None | 0 | 190 | 178 | 190 | View |
| Group 3: Placebo | Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase. | 0 | None | 4 | 208 | 133 | 208 | View |
| Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. | 0 | None | 3 | 417 | 391 | 417 | View |
| All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. | 0 | None | 7 | 625 | 524 | 625 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Type 1 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Reactive attachment disorder of infancy or early childhood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |