Adverse Events Module

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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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT00485134
Description: Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
Frequency Threshold: 0
Time Frame: Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Study: NCT00485134
Study Brief: Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 1: Group A, Dolphin 240 µg 240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™). 240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris. 0 None 0 12 10 12 View
Stage 1: Group B, Dolphin 480 µg 480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™). 480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris. 0 None 0 12 11 12 View
Stage 1: Group C, Dolphin 690 µg 690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™). 690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris. 0 None 0 12 11 12 View
Stage 2: Immunized The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast. Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T 0 None 0 41 41 41 View
Stage 2: Controls A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast. Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T 0 None 1 28 28 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT General disorders None View
Nasal burning SYSTEMATIC_ASSESSMENT General disorders None View
Nasal itching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Postnasal drip SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Sinus pain SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing SYSTEMATIC_ASSESSMENT General disorders None View
Itching eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Nose bleed SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Nasal mucosa hyperemia SYSTEMATIC_ASSESSMENT General disorders None View
Nasal discharge SYSTEMATIC_ASSESSMENT General disorders None View
Nasal edema SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT General disorders None View
Sinus tenderness SYSTEMATIC_ASSESSMENT General disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders None View
Conjunctival injection SYSTEMATIC_ASSESSMENT Eye disorders None View
Tearing SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal lung exam SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abnormal cranial nerve finding SYSTEMATIC_ASSESSMENT General disorders None View