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:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
NCT ID:
NCT01385566
Description:
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
Frequency Threshold:
5
Time Frame:
Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Study:
NCT01385566
Study Brief:
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 1/3 Dose Subcutaneous | Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | None | None | 0 | 34 | 10 | 34 | View |
| Full Dose Intradermal | Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | None | None | 0 | 34 | 27 | 34 | View |
| 1/3 Dose Intradermal | Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | None | None | 0 | 35 | 23 | 35 | View |
| 1/27 Dose Intradermal | Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | None | None | 0 | 34 | 19 | 34 | View |
| Full Dose Subcutaneous | Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. | None | None | 0 | 52 | 30 | 52 | View |
| 1/10 Dose Intradermal | Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | None | None | 0 | 34 | 21 | 34 | View |
| Placebo | On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only. | None | None | 0 | 39 | 5 | 39 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | None | General disorders | MedDRA (15.0) | View |
| Injection site induration | None | General disorders | MedDRA (15.0) | View |
| Injection site pain | None | General disorders | MedDRA (15.0) | View |
| Headache | None | Nervous system disorders | MedDRA (15.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Injection site pruritus | None | General disorders | MedDRA (15.0) | View |
| Injection site swelling | None | General disorders | MedDRA (15.0) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (15.0) | View |