InfluenzaPhase 1/2NCT00294099
H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
A Phase 1/2 study testing Aluminum hydroxide and Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Aluminum hydroxide and Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2006to Mar 2007
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Are ambulatory adults aged 65 and older
- Are in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg] oral temperature less than 100.0°F), medical history to ensure stable medical condition, and targeted physical examination based on medical history
- Are able to understand and comply with planned study procedures
- Provide written informed consent prior to initiation of any study procedures
- Stable medical condition - no 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 that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.
Who cannot join
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, aluminum hydroxide, and chicken protein).
- Have immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- 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 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.
Show all 21Show fewer
- Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate.) 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.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment 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. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dose adjustment within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
- Have a history of severe reactions following immunization with influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 7- to 8-month 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.
- Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- 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.
- Planned to travel outside of the USA in the time between the first vaccination and 56 days following the first vaccination.
- Have any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia.
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
University of Rochester
Rochester, New York, 14642
Saint Louis University
St Louis, Missouri, 63104
About this study
Official title: A Phase I-II, Randomized, Controlled, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Elderly Adults
The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.
Read the detailed description
This is a double-blind, randomized, controlled, dose-ranging, Phase I-II study in healthy ambulatory elderly adults. The primary objectives are to: determine the dose-related safety of subvirion-inactivated H5N1 vaccine adjuvanted with aluminum hydroxide in healthy elderly adults (65 years of age and older); determine the potential for aluminum hydroxide to enhance the immune response to subvirion inactivated H5N1 vaccine in healthy elderly adults approximately 1 month following receipt of 2 doses of vaccine; and provide information for the selection of the best dosage level for further studies. A secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. Approximately 600 elderly subjects are planned for enrollment. Subjects will be screened for health status by history and targeted physical examination. Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive 2 doses of nonadjuvanted or aluminum hydroxide-adjuvanted influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 micrograms of hemagglutinin (HA) by intramuscular injection. The first vaccination will occur on Day 0. Symptoms and signs will be assessed in the clinic for at least 15 minutes after inoculation, and 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 encouraged to take their temperature around the same time each day. All subjects will return to the clinic on Days 2 and 8 after each vaccination for assessment of AEs and concomitant medications, as well as a targeted physical examination if indicated. Memory aids will be reviewed at each visit. At approximately Day 28 after the first vaccination, subjects will return to the clinic for blood sample collection and safety follow-up, followed by a second vaccination. Safety follow-up will be identical to that performed after the first vaccination. Approximately 56 days after first immunization (or about 28 days after the second vaccination), subjects will return to the clinic for immunogenicity blood sample collection, AE and concomitant medication assessments, and targeted physical examinations (if indicated). At approximately Day 208 (7 months after the first vaccination), subjects will return to the clinic for a final immunogenicity blood sample collection and for follow-up, which includes a targeted physical examination if indicated. The duration of the study treatment for each subject will be about 7 months. The primary study endpoints include: AE or serious adverse event (SAE) information; proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine; and GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine. The secondary endpoints include: GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; GMT and frequency of 4-fold or greater increases i
- Conditions
- Influenza
- Being tested
- Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Keywords
- A/H5N1, Influenza, 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.
Aluminum hydroxideBiological
Aluminum hydroxide adjuvant.
Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Biological
Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | 120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 3 | Experimental | 60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 4 | Experimental | 60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 8 | Experimental | 60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 7 | Experimental | 60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 1 | Experimental | 120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 5 | Experimental | 60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 6 | Experimental | 60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine.
Measured: Approximately day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine.
Measured: Approximately day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Measured: Approximately day 56.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Measured: Approximately day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Measured: Adverse events will be collected through 28 days following the 2nd dose of vaccine (day 56). Serious adverse events will be collected throughout the study through day 208.
Secondary outcomes (3)
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Measured: Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Measured: Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Measured: Day 0, and at days 28, 56, and 208 after the first immunization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294099
- Sponsor's protocol ID
- 05-0141
- Status last verified
- Sep 2008
- First submitted
- 16 Feb 2006
- Last updated
- 3 Jun 2013
- Results posted
- No
Publications
Brady RC, Treanor JJ, Atmar RL, Keitel WA, Edelman R, Chen WH, Winokur P, Belshe R, Graham IL, Noah DL, Guo K, Hill H. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults. Vaccine. 2009 Aug 13;27(37):5091-5. doi: 10.1016/j.vaccine.2009.06.057. Epub 2009 Jul 3.
PubMed 19577636
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Randomized, Controlled, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Elderly Adults
- ClinicalTrials.gov ID
- NCT00294099
- Acronym / sponsor ID
- 05-0141
- Conditions
- Influenza
- Keywords
- A/H5N1, Influenza, Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 Feb 2006 (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 compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.
Detailed description
This is a double-blind, randomized, controlled, dose-ranging, Phase I-II study in healthy ambulatory elderly adults. The primary objectives are to: determine the dose-related safety of subvirion-inactivated H5N1 vaccine adjuvanted with aluminum hydroxide in healthy elderly adults (65 years of age and older); determine the potential for aluminum hydroxide to enhance the immune response to subvirion inactivated H5N1 vaccine in healthy elderly adults approximately 1 month following receipt of 2 doses of vaccine; and provide information for the selection of the best dosage level for further studies. A secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. Approximately 600 elderly subjects are planned for enrollment. Subjects will be screened for health status by history and targeted physical examination. Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive 2 doses of nonadjuvanted or aluminum hydroxide-adjuvanted influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 micrograms of hemagglutinin (HA) by intramuscular injection. The first vaccination will occur on Day 0. Symptoms and signs will be assessed in the clinic for at least 15 minutes after inoculation, and 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 encouraged to take their temperature around the same time each day. All subjects will return to the clinic on Days 2 and 8 after each vaccination for assessment of AEs and concomitant medications, as well as a targeted physical examination if indicated. Memory aids will be reviewed at each visit. At approximately Day 28 after the first vaccination, subjects will return to the clinic for blood sample collection and safety follow-up, followed by a second vaccination. Safety follow-up will be identical to that performed after the first vaccination. Approximately 56 days after first immunization (or about 28 days after the second vaccination), subjects will return to the clinic for immunogenicity blood sample collection, AE and concomitant medication assessments, and targeted physical examinations (if indicated). At approximately Day 208 (7 months after the first vaccination), subjects will return to the clinic for a final immunogenicity blood sample collection and for follow-up, which includes a targeted physical examination if indicated. The duration of the study treatment for each subject will be about 7 months. The primary study endpoints include: AE or serious adverse event (SAE) information; proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine; and GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine. The secondary endpoints include: GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; GMT and frequency of 4-fold or greater increases i
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. |
| 3 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. |
| 4 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. |
| 8 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. |
| 7 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. |
| 1 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. |
| 5 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide. |
| 6 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Are ambulatory adults aged 65 and older
- Are in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg] oral temperature less than 100.0°F), medical history to ensure stable medical condition, and targeted physical examination based on medical history
- Are able to understand and comply with planned study procedures
- Provide written informed consent prior to initiation of any study procedures
- Stable medical condition - no 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 that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.
Key exclusion criteria (21 listed)
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, aluminum hydroxide, and chicken protein).
- Have immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- 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 diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
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 |
|---|---|---|
| Aluminum hydroxideAluminum hydroxide adjuvant. | Biological | 1, 3, 5, 7 |
| Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28. | Biological | 1, 2, 3, 4, 5, 6, 7, 8 |
Primary outcome
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine.
Time frame: Approximately day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine.
Time frame: Approximately day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Time frame: Approximately day 56.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Time frame: Approximately day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Time frame: Adverse events will be collected through 28 days following the 2nd dose of vaccine (day 56). Serious adverse events will be collected throughout the study through day 208.
3 secondary outcomes
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Time frame: Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Time frame: Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Time frame: Day 0, and at days 28, 56, and 208 after the first immunization.
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 3 Jun 2013.
- Results publication: PubMed 19577636Brady RC, Treanor JJ, Atmar RL, Keitel WA, Edelman R, Chen WH, Winokur P, Belshe R, Graham IL, Noah DL, Guo K, Hill H. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults. Vaccine. 2009 Aug 13;27(37):5091-5. doi: 10.1016/j.vaccine.2009.06.057. Epub 2009 Jul 3.
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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.
7 sites 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 Aluminum hydroxide and Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 5 inclusion and 21 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 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine. (time frame: Approximately day 56.). The study lists 5 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 NCT00294099, 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 3 Jun 2013.