H1N1 InfluenzaNCT01008683
Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
An observational study of H1N1 Influenza, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. In these patients the investigators will measure the specific antibody production. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- H1N1 Influenza
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Jul 2010
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
Who may be able to join
- Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
Who cannot join
- Patients with unstable grafts.
Trial locations and contacts
1 site in 1 country.
Hadas Lemberg contact
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Dan Engelhard, engelhard@hadassah.org.il
About this study
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
In these patients the investigators will measure the specific antibody production.
Read the detailed description
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.
In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.
- Conditions
- H1N1 Influenza
- Keywords
- Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations
- Medical subject headings
- Orthomyxoviridae Infections
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 |
|---|---|---|
| Stem cell and and heart transplant patients | Stem cell and and heart transplant patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H1N1 InfluenzaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Dan Engelhard, Principal investigator, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008683
- Sponsor's protocol ID
- engelhard-HMO-CTIL
- Status last verified
- Nov 2009
- First submitted
- 5 Nov 2009
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation
- ClinicalTrials.gov ID
- NCT01008683
- Acronym / sponsor ID
- engelhard-HMO-CTIL
- Conditions
- H1N1 Influenza
- Keywords
- Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccinations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 6 Nov 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.
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
In these patients the investigators will measure the specific antibody production.
Detailed description
Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.
In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell and and heart transplant patients | – | –Stem cell and and heart transplant patients |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
Key inclusion criteria (1 listed)
- Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.
Key exclusion criteria (1 listed)
- Patients with unstable grafts.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2009.
Related trials for H1N1 Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Hadas Lemberg contact
Dan Engelhard principal investigator
Hadassah
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 Influenza, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Nov 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Lemberg (lhadas@hadassah.org.il), or a site near the patient. 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 6 Nov 2009.