InfluenzaPhase 2NCT00006146
Half-Dose Flu Vaccine Study in Healthy Adults
A Phase 2 study testing Approved influenza virus vaccine. in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Approved influenza virus vaccine.
- Type of treatment
- Vaccines
- How many people
- 840 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2000to Sep 2000
- Phase
- Phase 2
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers may be eligible for this trial if they:
- Are able to and have given informed consent.
- Are able to understand and comply with all study procedures and to complete study diary.
- Are aged 18 to 49 years.
- Are female, and are not pregnant.
- Are available for all study visits.
Who cannot join
- Volunteers will not be eligible for this trial if they:
- Are allergic to eggs or egg products.
- Have a current chronic medical condition for which influenza vaccine is normally recommended.
- Have received experimental vaccines or medications within 30 days of study entry.
- Have received parenteral immunoglobulin within 30 days of study entry.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp
Cincinnati, Ohio, 45206
Maryland CARES
College Park, Maryland
Baylor College of Medicine
Houston, Texas, 77030
Univ of Rochester Medical Center
Rochester, New York, 14642
Center for Vaccine Development
St Louis, Missouri, 63110
UCLA Center for Vaccine Research
Torrance, California, 90502
About this study
Official title: Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.
If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.
Read the detailed description
Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.
- Conditions
- Influenza
- Being tested
- Approved influenza virus vaccine.
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approved influenza virus vaccine.Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startAug 2000
- Study completionSep 2000
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 2
- Primary purpose
- Prevention
- Enrolment
- 840 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John Treanor, Principal investigator, Univ of Rochester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006146
- Sponsor's protocol ID
- DMID 00-009
- Status last verified
- Nov 2005
- First submitted
- 7 Aug 2000
- 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
- Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00006146
- Acronym / sponsor ID
- DMID 00-009
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Sep 2000
- First posted
- 31 Aug 2001 (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.
It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.
If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.
Detailed description
Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are able to and have given informed consent.
- Are able to understand and comply with all study procedures and to complete study diary.
- Are aged 18 to 49 years.
- Are female, and are not pregnant.
- Are available for all study visits.
Key exclusion criteria (5 listed)
- Are allergic to eggs or egg products.
- Have a current chronic medical condition for which influenza vaccine is normally recommended.
- Have received experimental vaccines or medications within 30 days of study entry.
- Have received parenteral immunoglobulin within 30 days of study entry.
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 |
|---|---|---|
| Approved influenza virus vaccine. | 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.
John Treanor principal investigator
Univ of Rochester Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Approved influenza virus vaccine. in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites 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 5 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 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.