Freedom of Information request on clinical trials involving 12 to 18 year olds (FOI 21/543)
Published 28 June 2021
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27th May 2021 FOI 21/543
Dear
Thank you for your enquiry dated 20th May 2021 which has been considered under the Freedom of Information (FOI) Act
You asked for the following:
• all available information on clinical trials involving the age group from 12 to 18 year olds for all Vaccines of Covid19. Noting;
• These should be made readily available to the public
There are three clinical trials approved in the UK involving the age group from 12 to 18 year olds for all COVID-19 vaccines.
Regarding the comment that information on such trials should be made available to the public, all three trials are registered on public databases and trial information is therefore in the public domain;
One trial is registered on the ISRCTN registry (https://www.isrctn.com/), located by searching for ‘ISRCTN15638344’.
Another trial is registered on ClinicalTrials.gov (https://clinicaltrials.gov/), located by searching for ‘NCT04535453’.
And the last registered on the EudraCT database (https://eudract.ema.europa.eu/), located by searching the EudraCT number 2020-005720-11.
We now consider this request closed.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk .
Please remember to quote the reference number above in any future communications.
Please note, due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU