InfluenzaPhase 4NCT00133510
Influenza Vaccine in Pediatric Transplant Subjects
A Phase 4 study testing Trivalent Subviron Influenza vaccine (Fluzone) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent Subviron Influenza vaccine (Fluzone)
- Type of treatment
- Vaccines
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Sep 2006
- Phase
- Phase 4
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely.
- Between the ages of 6 months and 17 years.
- Three months have elapsed since liver transplantation.
- Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant.
- Must have the ability to comply with the study procedures for the entire length of the study.
Who cannot join
- Previous immunization with an influenza vaccine for the 2004-2005 or 2005-2006 influenza season.
- Known hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
- History of Guillian-Barré syndrome.
- Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination.
- Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment.
- Subjects who have experienced an acute febrile illness within the preceding 48 hours will have immunization deferred and be rescheduled once their fever has resolved.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of the Humoral and Cell-Mediated Immune Responses to the Trivalent Subviron Influenza Vaccine in Pediatric Liver Transplant Recipients as an Indicator for Response of Immunocompromised Subjects to Vaccination Against Agents of Bioterrorism
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.
Read the detailed description
The purpose of this study is to investigate the humoral and cell-mediated immune response to the trivalent subviron influenza vaccine in pediatric liver transplant recipients. Additionally, researchers will attempt to correlate the humoral and cell-mediated immune response with parameters that may predict a subject's ability to respond to the vaccine, such as time from transplant, immunosuppressive agents, previous episodes of rejection or cytomegalovirus infection, T-cell numbers and T-cell responses to mitogens or antigens. Understanding the immune response to influenza will provide insight not only into the response to the trivalent subviron influenza vaccine but to other vaccines being developed against agents of bioterrorism, in particular those that may use influenza or related viruses as a backbone. This is a single center, prospective comparative study of the humoral and cell-mediated immune responses to the trivalent subviron influenza vaccine for the 2004-2005 and 2005-2006 influenza seasons in outpatient pediatric liver transplant recipients and their healthy siblings. There are two study arms, the liver transplant recipients (n=44) and the healthy controls (n=22). All study subjects will receive the vaccine at enrollment. Enrollment into this study will be extended into the 2005-2006 influenza season. The trivalent subviron influenza vaccine for the 2005-2006 influenza season will differ from that for the 2004-2005 influenza season with respect to the H3N2 viral strains. The cell-mediated and humoral immune responses of patients to the two H3N2 viral strains will be analyzed together and separately to assess potential differences in immunogenicity between the two viral strains. Humoral and cell-mediated immune responses will be obtained at baseline and following immunization. Healthy siblings are used as controls to ensure equal burden of influenza disease among study participants. Participants will be involved in study related procedures for up to 8 months.
- Conditions
- Influenza
- Being tested
- Trivalent Subviron Influenza vaccine (Fluzone)
- Keywords
- children, immunocompromised, influenza, liver transplant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Subviron Influenza vaccine (Fluzone)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startNov 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133510
- Sponsor's protocol ID
- 04-050
- Status last verified
- Mar 2008
- First submitted
- 19 Aug 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of the Humoral and Cell-Mediated Immune Responses to the Trivalent Subviron Influenza Vaccine in Pediatric Liver Transplant Recipients as an Indicator for Response of Immunocompromised Subjects to Vaccination Against Agents of Bioterrorism
- ClinicalTrials.gov ID
- NCT00133510
- Acronym / sponsor ID
- 04-050
- Conditions
- Influenza
- Keywords
- children, immunocompromised, influenza, liver transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2004
- Study completion
- Sep 2006
- First posted
- 23 Aug 2005 (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.
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.
Detailed description
The purpose of this study is to investigate the humoral and cell-mediated immune response to the trivalent subviron influenza vaccine in pediatric liver transplant recipients. Additionally, researchers will attempt to correlate the humoral and cell-mediated immune response with parameters that may predict a subject's ability to respond to the vaccine, such as time from transplant, immunosuppressive agents, previous episodes of rejection or cytomegalovirus infection, T-cell numbers and T-cell responses to mitogens or antigens. Understanding the immune response to influenza will provide insight not only into the response to the trivalent subviron influenza vaccine but to other vaccines being developed against agents of bioterrorism, in particular those that may use influenza or related viruses as a backbone. This is a single center, prospective comparative study of the humoral and cell-mediated immune responses to the trivalent subviron influenza vaccine for the 2004-2005 and 2005-2006 influenza seasons in outpatient pediatric liver transplant recipients and their healthy siblings. There are two study arms, the liver transplant recipients (n=44) and the healthy controls (n=22). All study subjects will receive the vaccine at enrollment. Enrollment into this study will be extended into the 2005-2006 influenza season. The trivalent subviron influenza vaccine for the 2005-2006 influenza season will differ from that for the 2004-2005 influenza season with respect to the H3N2 viral strains. The cell-mediated and humoral immune responses of patients to the two H3N2 viral strains will be analyzed together and separately to assess potential differences in immunogenicity between the two viral strains. Humoral and cell-mediated immune responses will be obtained at baseline and following immunization. Healthy siblings are used as controls to ensure equal burden of influenza disease among study participants. Participants will be involved in study related procedures for up to 8 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely.
- Between the ages of 6 months and 17 years.
- Three months have elapsed since liver transplantation.
- Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant.
- Must have the ability to comply with the study procedures for the entire length of the study.
Key exclusion criteria (6 listed)
- Previous immunization with an influenza vaccine for the 2004-2005 or 2005-2006 influenza season.
- Known hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
- History of Guillian-Barré syndrome.
- Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination.
- Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent Subviron Influenza vaccine (Fluzone) | Biological | – |
Primary outcome
Not reported in the source record.
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 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent Subviron Influenza vaccine (Fluzone) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 5 inclusion and 6 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 27 Aug 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 27 Aug 2010.