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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04785612
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.
Study:
NCT04785612
Study Brief:
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RSVPreF (From Vaccination Until Viral Challenge) | A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume RSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection on Day -28 | 0 | None | 0 | 35 | 12 | 35 | View |
| Placebo (From Vaccination Until Viral Challenge) | A single intramuscular injection of Placebo to match active vaccine Placebo: A single Placebo dose for intramuscular injection to match experimental vaccine on Day -28 | 0 | None | 0 | 35 | 9 | 35 | View |
| RSVPreF (From Viral Challenge Until Day 28) | Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 | 0 | None | 0 | 35 | 2 | 35 | View |
| Placebo (From Viral Challenge Until Day 28) | Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28. | 0 | None | 1 | 35 | 1 | 35 | View |
| RSVPreF (From Day 28 Until Day155) | Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0 | 0 | None | 1 | 35 | 2 | 35 | View |
| Placebo (From Day 28 Until Day155) | Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0 | 0 | None | 0 | 35 | 0 | 35 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | View |
| Myocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Localised infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Meningitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Varicella zoster virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |