H1N1 Pandemic FluNCT01000571
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
An observational study of H1N1 Pandemic Flu, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- H1N1 Pandemic Flu
- Type of treatment
- Vaccines
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.
Read the 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 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.
- Conditions
- H1N1 Pandemic Flu
- Keywords
- H1N1 pandemic flu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40).
Measured: 1.5 years
Secondary outcomes (1)
This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera).
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H1N1 Pandemic FluStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hana Hakim, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000571
- Sponsor's protocol ID
- SOVAC
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2009
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
- ClinicalTrials.gov ID
- NCT01000571
- Acronym / sponsor ID
- SOVAC
- Conditions
- H1N1 Pandemic Flu
- Keywords
- H1N1 pandemic flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40).
Time frame: 1.5 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Hakim, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of H1N1 Pandemic Flu, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40). (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.