InfluenzaPhase 1/2NCT00546585
Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults
A Phase 1/2 study testing Influenza A/H7N7 Vaccine 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 the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7 Vaccine] being given in increasing doses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza A/H7N7 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate < 100 beats per minute, blood pressure: systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg, diastolic less than or equal to 90 mm Hg; oral temperature < 100 degrees Fahrenheit), medical history to ensure stable* medical condition and a targeted physical examination based on medical history. (*A stable medical condition is defined as no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc, or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.)
- Able to understand and comply with planned study procedures.
- Provide informed consent prior to initiation of any study procedures and are available for all study visits.
Who cannot join
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, aluminum hydroxide, and chicken protein).
- Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed.)
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Show all 22Show fewer
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
- Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. (This includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expect to receive an experimental agent during the 7-month study period.
- Plan to enroll in another clinical trial at any time during the study period.
- Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
- Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Are receiving psychiatric drugs*. Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate
- Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Have a history of alcohol or drug abuse in the last 5 years.
- Plan to travel outside of the USA in the time between the first vaccination and 56 days following the first vaccination.
- Have a history of Guillain-Barre syndrome.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Department of Molecular Virology and Microbiology
Houston, Texas, 77030
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H7N7 Vaccine in Healthy Adults
The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7 Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.
Read the detailed description
This randomized, double-blinded, placebo-controlled, dose-ranging, Phase I/II, influenza study will compare the safety, reactogenicity, and immunogenicity of increasing doses of monovalent subvirion influenza A/H7N7 virus vaccine administered by intramuscular (IM) injection to healthy adults. A total of 125 healthy adults ranging from 18 to 40 years old will be enrolled at one site for this study. The subjects will be randomized to receive saline placebo or 7.5, 15, 45, or 90 mcg of the influenza A/H7N7 vaccine by intramuscular (IM) injection in an approximate 1:1:1:1:1 ratio (N=25/vaccine dose group and 25 in the placebo group). Subjects will receive 2 doses separated by approximately 28 days. Subjects will be observed in the clinic for a minimum of 30 minutes after inoculation. All subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will be contacted by telephone 1-3 days after vaccination to assess for the occurrence of AEs, and they will return to the clinic between Day 8 and 12 for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. Serum for immunogenicity evaluations will be obtained for subjects prior to the first vaccination, at Day 28 prior to the second vaccination, and on Days 56 and 208. A Safety Monitoring Committee (SMC) will review available 7 day safety data at approximately Day 20 following the first subject vaccination before administering the second dose of vaccine to any subjects. The primary objectives of the study will be: to determine the dose-related safety of subvirion inactivated H7N7 vaccine in healthy adults; to determine the dose-related immunogenicity of subvirion inactivated H7N7 vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dose levels for further studies. The secondary objective will be to evaluate the dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. The primary endpoints are: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment); the proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus 28 days after receipt of the second dose of vaccine (approximately Day 56); geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine; and GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine. Participants will be involved in study related procedures for approximately 7 months. This study is linked to DMID protocol 07-0060.
- Conditions
- Influenza
- Being tested
- Influenza A/H7N7 Vaccine, Placebo
- Keywords
- influenza, inactivated influenza A/H7N7 vaccine, parent protocol
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A/H7N7 VaccineBiological
Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.
PlaceboDrug
Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.
| Study group | Role | What they receive |
|---|---|---|
| 90 mcg of Influenza A/H7N7 | Experimental | 25 subjects to receive 90 mcg of Influenza A/H7N7. Receives: Biological: Influenza A/H7N7 Vaccine |
| 15 mcg of Influenza A/H7N7 | Experimental | 25 subjects to receive 15 mcg of Influenza A/H7N7. Receives: Biological: Influenza A/H7N7 Vaccine |
| 7.5 mcg of Influenza A/H7N7 | Experimental | 25 subjects to receive 7.5 mcg of Influenza A/H7N7. Receives: Biological: Influenza A/H7N7 Vaccine |
| 45 mcg of Influenza A/H7N7 | Experimental | 25 subjects to receive 45 mcg of Influenza A/H7N7. Receives: Biological: Influenza A/H7N7 Vaccine |
| Saline placebo | Placebo comparator | 25 subjects to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Measured: Duration of study.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus.
Measured: 28 days after receipt of the second dose of vaccine (approximately Day 56).
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group.
Measured: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546585
- Sponsor's protocol ID
- 07-0023
- Status last verified
- Jan 2010
- First submitted
- 18 Oct 2007
- Last updated
- 23 Aug 2013
- Results posted
- No
Publications
Couch RB, Patel SM, Wade-Bowers CL, Nino D. A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. PLoS One. 2012;7(12):e49704. doi: 10.1371/journal.pone.0049704. Epub 2012 Dec 11.
PubMed 23239968
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H7N7 Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00546585
- Acronym / sponsor ID
- 07-0023
- Conditions
- Influenza
- Keywords
- influenza, inactivated influenza A/H7N7 vaccine, parent protocol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Oct 2007 (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 the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7 Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.
Detailed description
This randomized, double-blinded, placebo-controlled, dose-ranging, Phase I/II, influenza study will compare the safety, reactogenicity, and immunogenicity of increasing doses of monovalent subvirion influenza A/H7N7 virus vaccine administered by intramuscular (IM) injection to healthy adults. A total of 125 healthy adults ranging from 18 to 40 years old will be enrolled at one site for this study. The subjects will be randomized to receive saline placebo or 7.5, 15, 45, or 90 mcg of the influenza A/H7N7 vaccine by intramuscular (IM) injection in an approximate 1:1:1:1:1 ratio (N=25/vaccine dose group and 25 in the placebo group). Subjects will receive 2 doses separated by approximately 28 days. Subjects will be observed in the clinic for a minimum of 30 minutes after inoculation. All subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will be contacted by telephone 1-3 days after vaccination to assess for the occurrence of AEs, and they will return to the clinic between Day 8 and 12 for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. Serum for immunogenicity evaluations will be obtained for subjects prior to the first vaccination, at Day 28 prior to the second vaccination, and on Days 56 and 208. A Safety Monitoring Committee (SMC) will review available 7 day safety data at approximately Day 20 following the first subject vaccination before administering the second dose of vaccine to any subjects. The primary objectives of the study will be: to determine the dose-related safety of subvirion inactivated H7N7 vaccine in healthy adults; to determine the dose-related immunogenicity of subvirion inactivated H7N7 vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dose levels for further studies. The secondary objective will be to evaluate the dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. The primary endpoints are: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment); the proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus 28 days after receipt of the second dose of vaccine (approximately Day 56); geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine; and GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine. Participants will be involved in study related procedures for approximately 7 months. This study is linked to DMID protocol 07-0060.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 90 mcg of Influenza A/H7N7 | Experimental | Biological: Influenza A/H7N7 Vaccine25 subjects to receive 90 mcg of Influenza A/H7N7. |
| 15 mcg of Influenza A/H7N7 | Experimental | Biological: Influenza A/H7N7 Vaccine25 subjects to receive 15 mcg of Influenza A/H7N7. |
| 7.5 mcg of Influenza A/H7N7 | Experimental | Biological: Influenza A/H7N7 Vaccine25 subjects to receive 7.5 mcg of Influenza A/H7N7. |
| 45 mcg of Influenza A/H7N7 | Experimental | Biological: Influenza A/H7N7 Vaccine25 subjects to receive 45 mcg of Influenza A/H7N7. |
| Saline placebo | Placebo comparator | Drug: Placebo25 subjects to receive placebo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate < 100 beats per minute, blood pressure: systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg, diastolic less than or equal to 90 mm Hg; oral temperature < 100 degrees Fahrenheit), medical history to ensure stable* medical condition and a targeted physical examination based on medical history. (*A stable medical condition is defined as no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc, or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.)
- Able to understand and comply with planned study procedures.
- Provide informed consent prior to initiation of any study procedures and are available for all study visits.
Key exclusion criteria (22 listed)
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, aluminum hydroxide, and chicken protein).
- Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed.)
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 |
|---|---|---|
| Influenza A/H7N7 VaccineMonovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28. | Biological | 15 mcg of Influenza A/H7N7, 45 mcg of Influenza A/H7N7, 7.5 mcg of Influenza A/H7N7, 90 mcg of Influenza A/H7N7 |
| PlaceboSterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28. | Drug | Saline placebo |
Primary outcome
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Time frame: Duration of study.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus.
Time frame: 28 days after receipt of the second dose of vaccine (approximately Day 56).
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group.
Time frame: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
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 23 Aug 2013.
- Results publication: PubMed 23239968Couch RB, Patel SM, Wade-Bowers CL, Nino D. A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. PLoS One. 2012;7(12):e49704. doi: 10.1371/journal.pone.0049704. Epub 2012 Dec 11.
Related trials for Influenza
Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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 1/2 study testing Influenza A/H7N7 Vaccine 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 22 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 23 Aug 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). (time frame: Duration of study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546585, which also lists 1 linked publication.
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 23 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.