Status:
COMPLETED
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
H1N1 Pandemic Flu
Eligibility:
All Genders
6-21 years
Brief Summary
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01000571
Start Date
October 1 2009
End Date
June 1 2011
Last Update
October 7 2011
Active Locations (1)
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1
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105