By Todd Neale, Staff Writer, MedPage Today
Published: August 18, 2009
Two trials of vaccine against the 2009 H1N1 (swine flu) virus will begin in children shortly, according to the National Institute of Allergy and Infectious Diseases (NIAID).
Two trials of vaccine against the 2009 H1N1 (swine flu) virus will begin in children shortly, according to the National Institute of Allergy and Infectious Diseases (NIAID).
An independent safety monitoring committee recommended that the trials go forward after reviewing safety data on more than 500 healthy adult volunteers taking part in three H1N1 vaccine trials that started Aug. 7. NIAID accepted the recommendation.
The two trials will be conducted through the agency's nationwide vaccine research network and will evaluate the candidate H1N1 vaccine made by Sanofi Pasteur. The vaccine does not include an adjuvant.
The first trial, led by the vaccine and treatment evaluation unit at the University of Maryland in Baltimore, will evaluate two different strengths of vaccine -- 15 and 30 mcg.
It will include as many as 650 children, ages 6 months to 17 years, who will receive two doses of vaccine three weeks apart.
Other sites taking part in this study will be Vanderbilt University in Nashville, Duke University in Durham, NC, Children's Mercy Hospital in Kansas City, Mo., and Children's Hospital in Seattle.
The second trial will include a similar number of children and will determine whether the H1N1 vaccine is safe and effective when given before, after, or along with the seasonal flu vaccine.
Participants for this study will be drawn from Saint Louis University, which is leading the study, Baylor College of Medicine in Houston, Cincinnati Children's Hospital, Emory University in Atlanta, the University of Iowa in Iowa City, and the University of Texas Medical Branch at Galveston.
The trials are scheduled to be completed in April and June next year, but initial immunogenicity results should be available in the next several weeks, according to NIAID.