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 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
NCT ID:
NCT03295318
Description:
None
Frequency Threshold:
0
Time Frame:
Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
Study:
NCT03295318
Study Brief:
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Non-adjuvanted NmCV-5 Dose 1 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. First dose to be administered is 0.5 mL intramuscularly. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. | 1 | None | 1 | 149 | 41 | 149 | View |
| Adjuvanted NmCV-5 Dose 1 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. First dose to be administered is 0.5 mL intramuscularly. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine | 1 | None | 1 | 150 | 44 | 150 | View |
| Menactra Dose 1 | Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. | 0 | None | 0 | 76 | 25 | 76 | View |
| Non-adjuvanted NmCV-5 Dose 2 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. | 0 | None | 0 | 144 | 24 | 144 | View |
| Adjuvanted NmCV-5 Dose 2 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine | 0 | None | 0 | 145 | 17 | 145 | View |
| Menactra Dose 2 | Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. | 1 | None | 1 | 73 | 16 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Burns second degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.1 | View |
| Escheria Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection Site Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Injection Site Swelling/Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Decrease Eating | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |
| Thermal Burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.1 | View |
| Allergic Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.1 | View |