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


N/A
6 Months
21 Years
Not Enrolling
Both
H1N1 Pandemic Flu

Thank you

Trial Information

Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40).

Outcome Time Frame:

1.5 years

Safety Issue:

Yes

Principal Investigator

Hana Hakim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

SOVAC

NCT ID:

NCT01000571

Start Date:

October 2009

Completion Date:

June 2011

Related Keywords:

  • H1N1 Pandemic Flu
  • H1N1 pandemic flu
  • Influenza, Human

Name

Location

St.Jude Children's Research HospitalMemphis, Tennessee  38105