Sanofi Pasteur has announced that data from the first clinical trial of its Influenza A (H1N1) 2009 Monovalent Vaccine in children has shown a positive immune response and is well tolerated.

The trial data indicates that for children aged six months to nine years, the vaccine is immunogenic and that two doses of vaccine will be required for optimum protection of all children under the age of ten.

Clinical trials are underway to evaluate the immunogenicity and safety in children following two doses of the vaccine.

Sanofi Pasteur president and CEO Wayne Pisano said that young children are among those of highest priority for immunisation against the flu pandemic.

“As the only company licensed in the US to produce a paediatric influenza vaccine, evaluating the safety and immunogenicity of the pandemic vaccine in children was of the highest priority,” Pisano said.

The randomised, placebo-controlled, multicentre trial was conducted to determine the immunogenicity and safety of the vaccine, given as a two-dose schedule, 21 days apart.

A total of 474 children were enrolled in the trial in two age groups: 229 children six months through 35 months of age; and 245 children aged three years through to nine years.

Final data from these clinical trials, following a second dose of the vaccine, will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.