Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
Completed
Conditions studied: H1N1 Pandemic Flu
In brief
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.
Key facts
- Study ID
- NCT01000571
- Run by
- St. Jude Children's Research Hospital
- People needed
- 104
- Starts
- 2009-10-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2011-10-07
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- St.Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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