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Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01000571
First received: October 19, 2009
Last updated: October 5, 2011
Last verified: October 2011
History of Changes

October 19, 2009
October 5, 2011
October 2009
June 2011   (final data collection date for primary outcome measure)
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40). [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40). [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01000571 on ClinicalTrials.gov Archive Site
This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera). [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera). [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample collection will be done according to the description provided in the institutional policy manual. When possible, blood draws will be made through existing implanted catheters. If the research participant does not have a catheter, a peripheral venipuncture will be performed. Serum and whole blood for immune assays will be frozen at -20ºC or in liquid nitrogen until processed in batched assays.
Probability Sample

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. Stem cell transplant recipients in the first year following their transplant are excluded.
H1N1 Pandemic Flu
Not Provided
H1N1 pandemic influenza vaccine recipient
Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions 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.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01000571
SOVAC
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Hana Hakim, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP