London - A new vaccine from GlaxoSmithKline Plc could help to reduce middle ear infection, a common problem in toddlers, scientists have said.
Researchers at the University of Defence 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 3 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 antibiotics.
Prymula and his team tested the vaccine on nearly 5 000 infants who were either given three doses of the new vaccine N Streptorix - and a booster before 15-months-old or a vaccine for hepatitis A.
Children who received the hepatitis vaccine acted as the control group.
"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 by 2010 from £600-million in 2004.
(Additional reporting by Ben Hirschler)