Evaluation for the risk of allergy to COVID-19 vaccines in people with history of allergy diathesis.

Not Applicable

Completed

• Conditions: Health Condition 1: T784- Other and unspecified allergy

• Registration Number: CTRI/2021/09/036832
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-16
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Participants with history of anaphylaxis or allergic reaction or any allergies.

Participants who are yet unvaccinated to COVID-19 vaccine OR Participants who have taken the first dose of COVID-19 vaccine, due for the second dose OR Participants who have taken second dose of COVID-19 vaccine, due for precautionary dose OR Participant who have history of allergic reaction to first and/or second dose of COVID-19 vaccine.(Any one of these criteria should be satisfied)

Participant of either gender of more than 18 years.

Participants who are able to provide a written informed consent or have a legally accepted representative [LAR] to provide the same.

Exclusion Criteria

Participants who are participating in any other clinical trial or experimental treatment for COVID-19.

Participants who are not deemed fit as per the investigator or his/her team for any other medical reason.

Female participants who are pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with negative skin test with both COVISHIELD vaccine, Polysorbate 80 and/or PEG among the total number of participants. <br/ ><br>Proportion of participants with negative skin test with COVISHIELD vaccine and positive with Polysorbate 80 and/or PEG among the total number of participants.Timepoint: Day Zero

Secondary Outcome Measures

Name	Time	Method
Occurrence of unsolicited and solicited local and systemic adverse events after each dose of vaccine. <br/ ><br>Occurrence of unsolicited and solicited serious adverse events after each dose of vaccine. <br/ ><br>Timepoint: 6 to 8 hours and 72 hours after each dose of vaccine.