Two trials are underway to test the safety and efficacy of a candidate pediatric vaccine for novel influenza A(H1N1).
An independent safety monitoring committee recommended in mid-August that trials of a candidate vaccine begin in children. The National Institute of Allergy and Infectious Diseases (NIAID) concurred with the recommendation. The two trials are being conducted through the agency's Vaccine and Treatment Evaluation Unit (VTEU) network.
The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate novel H1N1 vaccines that began Aug. 7 and found no safety concerns in those trials that would preclude the start of pediatric trials, the NIAID said in a statement.
One trial is investigating the immune response to two different strengths of a candidate vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland, Baltimore, the trial is enrolling up to 650 children aged 6 months to 17 years at five locations. Immune responses will be measured following doses of either 15 mcg or 30 mcg of vaccine at the first visit and a second dose 3 weeks later.
The second trial, led by the VTEU at St. Louis University and occurring at five other institutions, is testing administration of seasonal influenza vaccine along with a candidate novel H1N1 vaccine. The study will assess the candidate vaccine's safety and how immune responses vary when the novel H1N1 vaccine is given before, after, or at the same time as the seasonal vaccine.