Studies show GlaxoSmithKline rotavirus vaccine candidate effective against disease

By E. Janene Geiss

Philadelphia, Jan. 4 - Data from one of the largest infant vaccine trials ever conducted, published today in the New England Journal of Medicine, showed GlaxoSmithKline's rotavirus vaccine candidate as effective against rotavirus disease (rotavirus gastroenteritis) in the first year of life, according to a company news release.

Rotavirus is the leading recognized cause of diarrhea-related illness and death among infants and young children. Every year, rotavirus is associated with an estimated 25 million clinic visits, two million hospitalizations and more than 600,000 deaths worldwide among children younger than five years of age, the release said.

In the United States, the Centers for Disease Control and Prevention estimates the annual rotavirus disease burden among children younger than 5 years old as 2.7 million illnesses, resulting in 410,000 clinic visits, up to 70,000 hospitalizations and 20 to 70 deaths.

Results from a double-blind, placebo-controlled trial demonstrated that two doses of the rotavirus vaccine candidate given two months apart at two-months and four-months of age, gave 85% protection against severe rotavirus disease and 100% protection against more severe disease, officials said.

This protection was proven against the most common circulating strains: G1P[8], G3P[8], G4P[8] and the globally emerging G9P[8] strain.

A meta-analysis considering data from this trial and other efficacy studies conducted with similar methods showed 67% protection against G2P[4] rotavirus disease, officials said.

The safety analysis revealed a lower incidence of serious adverse events in children receiving the rotavirus vaccine candidate compared to children receiving placebo.

This finding was attributable to the lower number of gastrointestinal disease-related serious adverse events in those receiving the rotavirus vaccine candidate.

In addition, the safety analysis looked for, but did not find, any evidence of an increased risk for intussusception in recipients of the vaccine candidate compared to placebo. Intussusception is a complication of the intestines that was observed with a previously marketed rotavirus vaccine.

A total of 63,225 infants from 12 countries were enrolled in the study. Infants were randomly assigned to receive two oral doses of either the rotavirus vaccine candidate or placebo.

From administration of the first dose until one to three months after administration of the second dose, the entire study population was followed for the assessment of intussusception and serious adverse events. In addition, a subgroup of 20,169 was followed up to one year of age for the assessment of efficacy, officials said.

"Rotavirus is highly contagious regardless of sanitary conditions. Rotavirus can be detected in about one-third of all children hospitalized for diarrhea worldwide and mortality remains highest in the developing world. The now published data give confidence that vaccination at an early age has the potential to provide protection prior to the peak incidence of rotavirus at 6 to 24 months of age," Beatrice De Vos, director of worldwide medical affairs at GlaxoSmithKline Biologicals, said in the release.

Since its launch in Mexico in 2005, the rotavirus vaccine candidate has been licensed in several additional countries worldwide, including Brazil, Philippines and Singapore. The vaccine received a positive opinion from the Committee for Medicinal Products for Human Use, the committee that evaluates quality, safety and efficacy of medicinal products in the European Union. Marketing applications have been filed in 75 countries.

The vaccine candidate is not approved in the United States, but the company said it plans to file a Biologics License Application and discussions are ongoing with the Food and Drug Administration, officials said.

Recently, Brazil and Panama included for the first time the rotavirus vaccine in their national official vaccination calendars. As part of the government's pediatric immunization program, vaccination with the company's rotavirus vaccine will be available free at public health clinics in Brazil and Panama.

GlaxoSmithKline is a pharmaceutical and health care company based in London.

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