The Phase III trial of the two-dose vaccination will be carried out
in nine hospitals throughout Spain on volunteers both with and
without previous health conditions, the AEMPS agency said in a
statement.
J&J started mid-stage phase II trials in Spain and other countries
in September and launched a late-stage trial in Britain on Monday.
The Phase III trials will be carried out on 30,000 volunteers in
nine countries.
The two-dose study will run in parallel with a trials of a single
shot regimen involving 60,000 participants which was launched in
September.
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The Spanish hospitals involved in the trials will enrol volunteers
as soon as possible, the AEMPS said, adding that 20% will be younger
than 40 and 30% older than 60.
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They will be given a first dose of either a placebo or the experimental shot,
currently called Ad26COV2, followed by a second dose or placebo later.
Conclusions will only be available after analysing the data at the end of the
trials, the Spanish medicines agency said.
The news comes after Pfizer <PFE.N> and BioNTech <BNTX.O>, Russia and Moderna <MRNA.O>
all released interim data from Phase III trials of their potential vaccines
showing more than 90% efficacy, boosting hopes that vaccines against the
pandemic disease may be ready for use soon.
(Reporting by Inti Landauro and Ingrid Melander; Editing by Josephine Mason and
David Clarke)
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