Health Condition 1: T784- Other and unspecified allergy
Conditions
Interventions
Intervention1: Skin test (Skin prick test and intradermal test) for the assessment of allergic response to COVISHIELD vaccine, Polysorbate 80 and PEG (Poly ethylene glycol).: Skin test (Skin prick tes
Sponsors
ICMR
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with negative skin test with both COVISHIELD vaccine, Polysorbate 80 and/or PEG among the total number of participants. 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
| Measure | Time frame |
|---|---|
| Occurrence of unsolicited and solicited local and systemic adverse events after each dose of vaccine. Occurrence of unsolicited and solicited serious adverse events after each dose of vaccine. Timepoint: 6 to 8 hours and 72 hours after each dose of vaccine. | — |
Countries
India
Contacts
Public ContactDr Dhruve Soni
Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012
Outcome results
None listed