InfluenzaPhase 1/2NCT00296634
H5 Vaccine Alone or With Adjuvant in Healthy Adults
A Phase 1/2 study testing Aluminum hydroxide and Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum… 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?
- Aluminum hydroxide and Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2006to Dec 2006
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are males or nonpregnant females between the ages of 18 and 49 years, inclusive.
- Agree to practice adequate contraception (i.e., barrier methods, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period if they are females of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year).
- Are in good health as determined by vital signs, 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 a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, 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 mcg/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.
Show all 21Show fewer
- Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- 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 vaccination in this study.
- 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 F, 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.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them 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 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
4 sites in 1 country.
United States4 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Duke University Medical Center
Durham, North Carolina, 27704
Baylor College of Medicine
Houston, Texas, 77030
University of Rochester
Rochester, New York, 14642
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 Adults
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved in study related procedures for up to 8 months.
Read the detailed description
This randomized, controlled, double-blinded, dose-ranging, Phase I/II study in healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. The primary objectives are to: determine the dose-related safety of subvirion-inactivated H5N1 vaccine adjuvanted with aluminum hydroxide in healthy adults; determine the potential for aluminum hydroxide to enhance the immune response to subvirion-inactivated H5N1 vaccine in healthy 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. The secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of hemagglutinin (HA) with or without aluminum hydroxide adjuvant by intramuscular (IM) injection (N=60 or 120/vaccine dose group). 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 the 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 2 days and 8 days after each vaccination for assessment of adverse events (AEs) and concomitant medications and targeted physical examination (if indicated). Memory aids will be reviewed at each visit. 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. 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 assessment, and targeted physical examination (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]). Blood samples collected prior to each vaccination and on Days 56 and 208 after the first vaccination will be tested in a central laboratory for the levels of neutralizing and HAI antibodies. The primary outcome measures will be the frequencies and severities of AEs in each group and the proportions of subjects who achieve a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses (including frequencies of 4 fold or greater rise in titers; geometric mean titers; and proportions of subjects achieving putative protective titers of neutralizing antibody 1 month after each dose of vaccine and 7 months after first dose) also will be assessed. Although the correlate of protection for infections caused by influenza A/H5N1 viruses in humans is unknown, a serum neutralizing antibody titer of greater than or equal to 1:40 may be considered protective, based on limited data regarding the levels of serum neutralizing antibody present in serum samples collected from humans who survived infections caused by influenza A/H5N1 viruses. This study is linked to DMID protocol 07-0022.
- Conditions
- Influenza
- Being tested
- Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)
- Keywords
- H5N1, Influenza, vaccine
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum hydroxideDrug
Aluminum hydroxide adjuvant at 1200 mcg/mL.
Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)Biological
Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant. All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection. Vaccine with adjuvant is a turbid liquid whitish-grey in color. Vaccine without adjuvant is essentially clear and slightly opalescent in color.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 45 microgram dose Hemagglutinin (HA), 120 subjects receiving Aluminum hydroxide and 120 not receiving Aluminum hydroxide. Receives: Drug: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) |
| 2 | Experimental | 15 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. Receives: Drug: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) |
| 4 | Experimental | 3.75 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. Receives: Drug: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) |
| 3 | Experimental | 7.5 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. Receives: Drug: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) |
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 the clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Measured: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
Proportion of subjects in each group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus.
Measured: 28 days following 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.
Measured: 28 days following second dose of vaccine.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Measured: 28 days following second dose of vaccine.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Measured: 28 days after receipt of the second dose of vaccine.
Secondary outcomes (3)
1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Measured: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in serum HAI antibody titers.
Measured: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Measured: Blood samples for serum assays will be collected at 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 posted27 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionDec 2006
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296634
- Sponsor's protocol ID
- 05-0127
- Status last verified
- Sep 2008
- First submitted
- 23 Feb 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Publications
Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, Noah DL, Hill H. Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial. J Infect Dis. 2008 Nov 1;198(9):1309-16. doi: 10.1086/592172.
PubMed 18808338
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
- 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 Adults
- ClinicalTrials.gov ID
- NCT00296634
- Acronym / sponsor ID
- 05-0127
- Conditions
- Influenza
- Keywords
- 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
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 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.
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved in study related procedures for up to 8 months.
Detailed description
This randomized, controlled, double-blinded, dose-ranging, Phase I/II study in healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. The primary objectives are to: determine the dose-related safety of subvirion-inactivated H5N1 vaccine adjuvanted with aluminum hydroxide in healthy adults; determine the potential for aluminum hydroxide to enhance the immune response to subvirion-inactivated H5N1 vaccine in healthy 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. The secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of hemagglutinin (HA) with or without aluminum hydroxide adjuvant by intramuscular (IM) injection (N=60 or 120/vaccine dose group). 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 the 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 2 days and 8 days after each vaccination for assessment of adverse events (AEs) and concomitant medications and targeted physical examination (if indicated). Memory aids will be reviewed at each visit. 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. 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 assessment, and targeted physical examination (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]). Blood samples collected prior to each vaccination and on Days 56 and 208 after the first vaccination will be tested in a central laboratory for the levels of neutralizing and HAI antibodies. The primary outcome measures will be the frequencies and severities of AEs in each group and the proportions of subjects who achieve a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses (including frequencies of 4 fold or greater rise in titers; geometric mean titers; and proportions of subjects achieving putative protective titers of neutralizing antibody 1 month after each dose of vaccine and 7 months after first dose) also will be assessed. Although the correlate of protection for infections caused by influenza A/H5N1 viruses in humans is unknown, a serum neutralizing antibody titer of greater than or equal to 1:40 may be considered protective, based on limited data regarding the levels of serum neutralizing antibody present in serum samples collected from humans who survived infections caused by influenza A/H5N1 viruses. This study is linked to DMID protocol 07-0022.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)45 microgram dose Hemagglutinin (HA), 120 subjects receiving Aluminum hydroxide and 120 not receiving Aluminum hydroxide. |
| 2 | Experimental | Drug: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)15 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. |
| 4 | Experimental | Drug: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)3.75 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. |
| 3 | Experimental | Drug: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)7.5 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are males or nonpregnant females between the ages of 18 and 49 years, inclusive.
- Agree to practice adequate contraception (i.e., barrier methods, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period if they are females of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year).
- Are in good health as determined by vital signs, 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.
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 a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, 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 mcg/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 |
|---|---|---|
| Aluminum hydroxideAluminum hydroxide adjuvant at 1200 mcg/mL. | Drug | 1, 2, 3, 4 |
| Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant. All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection. Vaccine with adjuvant is a turbid liquid whitish-grey in color. Vaccine without adjuvant is essentially clear and slightly opalescent in color. | Biological | 1, 2, 3, 4 |
Primary outcome
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Time frame: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
Proportion of subjects in each group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus.
Time frame: 28 days following 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.
Time frame: 28 days following second dose of vaccine.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Time frame: 28 days following second dose of vaccine.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Time frame: 28 days after receipt of the second dose of vaccine.
3 secondary outcomes
1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Time frame: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in serum HAI antibody titers.
Time frame: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Time frame: Blood samples for serum assays will be collected at 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 27 Aug 2010.
- Derived from this study: PubMed 18808338Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, Noah DL, Hill H. Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial. J Infect Dis. 2008 Nov 1;198(9):1309-16. doi: 10.1086/592172.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
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
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.
4 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 pre-adsorbed) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 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 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 4 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?
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessments). (time frame: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.). 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 NCT00296634, 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 27 Aug 2010.