Food and Drug AdministrationImportant note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Click here to return to FDA main menu
DonateNow
Print this Article


Development of Preventive HIV Vaccines for Use in Pediatric Populations

Food and Drug Administration - May 5, 2006
Richard Klein

FDA is issuing guidance providing recommendations to sponsors regarding data to support the: 1) Initiation of pediatric studies of a preventive HIV vaccine under a United States (U.S.) investigational new drug application (IND); and 2) licensure of a preventive HIV vaccine for pediatric use. The guidance also provides recommendations to investigators and institutional review boards (IRBs) who are involved with these pediatric studies.

This guidance specifically addresses issues regarding development of a preventive HIV vaccine for use in healthy U.S. pediatric populations.

The guidance is available on the FDA web site at http://www.fda.gov/cber/gdlns/pedhiv.htm. Copies of this guidance are also available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800.

Written comments on this guidance may be submitted at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. You should identify all comments with the title of this guidance, Development of Preventive HIV Vaccines for Use in Pediatric Populations.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration


060505
FD060502

SOURCE: Food and Drug Administration (FDA).

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .