View Clinical Trial (Medical Research Study)

Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults - NCT01000571-38105(Clinical Trial 379038)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Memphis
State:  
TN
Zip Code: 38105
Conditions: H1N1 Pandemic Flu
Purpose: This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.
Study summary: This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review. Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.
Criteria: Inclusion Criteria: - Age 6 months through 21 years of age at the time of entry into the study; - Body weight of 13 kg or greater at the time of entry into the study; - Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant; - Participant or participant's parent/legal guardian available by telephone during the course of the study; - Written informed consent (and assent, if applicable) obtained; - Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry. Exclusion Criteria: - Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry; - Receipt of a stem cell transplant within one year prior to study entry; - Participation in P1088 study.
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.