March 3, 2006
Glaxo vaccine reduces ear infection in toddlers
LONDON (Reuters) - A new vaccine from GlaxoSmithKline Plc
could help to reduce middle ear infection, a common problem in
toddlers, scientists said on Friday.
Researchers at the University of Defense in Hradec Kralove
in the Czech Republic said the vaccine they tested against
middle ear infection, or otitis media, reduced cases of the
illness by about 30 percent in babies who had been vaccinated
in the first six months of life.
"We found a reduction in ear, nose and throat
specialist-confirmed episodes of acute otitis media by about a
third in infants in the vaccine group compared with controls,"
said Dr Roman Prymula, who headed the Phase III study reported
in the Lancet medical journal.
Middle ear infection causes fever, pain and sometimes a
decrease in hearing. The infection often follows a cold. It is
most common in young children and is usually treated with
Prymula and his team tested the vaccine on nearly 5,000
infants who were either given three doses of the new vaccine --
Streptorix -- and a booster before 15-months-old or a vaccine
for hepatitis A.
Children who received the hepatitis vaccine acted as the
"This study showed a statistically significant and
clinically relevant reduction in episodes of acute otitis
media," Prymula added.
Glaxo aims to position Streptorix as an improvement on
Wyeth's Prevnar and plans to submit the product for regulatory
approval in Europe in 2007. It has not given a filing date for
the United States.
Europe's biggest drug maker said last year it believed
Streptorix could help more than double the global market for
vaccines against Streptococcus pneumoniae to 1.25 billion to
1.75 billion pounds ($2.2 billion to $3.1 billion) by 2010 from
600 million pounds in 2004.
(Additional reporting by Ben Hirschler)