InfluenzaPhase 1NCT01317745
H5N1 Mix and Match With MF59
A Phase 1 study testing Phosphate Buffered Saline (PBS) diluent, MF59 Adjuvant and H5N1 Antigen in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. 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?
- Phosphate Buffered Saline (PBS) diluent, MF59 Adjuvant and H5N1 Antigen
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2011to Sep 2012
- Phase
- Phase 1
- 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 non-pregnant females between the ages of 18 and 49 years, inclusive.
- Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for >/=1 year) must agree to practice adequate contraception (that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods) during the study for at least 30 days following the last vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
- Are in good health, as determined by vital signs (oral temp, pulse and blood pressure), medical history and complete physical examination (without genital and rectal exam) to ensure no existing chronic medical diagnoses or conditions are present.
- ESR less than 30 mm per hour.
- For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the first vaccination.
- Are able to understand and comply with planned study procedures.
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- Provide written informed consent prior to initiation of any study procedures.
- Have received the first dose of study vaccine.
- For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the second vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
Who cannot join
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal and chicken protein), or allergy to squalene-based adjuvants.
- Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination.
- Have long term use (defined as taken for 2 weeks or more in total at any time during the past 2 months) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids); or high-dose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent); or systemic corticosteroids of any dose within the past 4 weeks.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
Show all 46Show fewer
- Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- Receiving systemic, prescription medications for the treatment of chronic medical conditions, unless such use is on a PRN (as needed) basis only. Non-PRN use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Note: Topical, nasal, and inhaled medications; vitamins; and contraceptives are also permitted.
- Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged.
- Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to the first vaccination..
- Received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to the first vaccination or plan receipt of such vaccines within 42 days following the first vaccination. This is inclusive of licensed seasonal influenza vaccines.
- Have an acute or chronic medical condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would render vaccination unsafe, would interfere with the evaluation of responses or is not generally seen in "normal, healthy subjects".
- Have a history of severe reactions following previous immunization with contemporary influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than or equal to 100.4 degrees F, within 3 days prior to the first vaccination.
- Pulse is less than 40 bpm or greater than 100 bpm. An ECG documenting only sinus bradycardia is required for pulses less than 50 bpm.
- Systolic blood pressure is less than 90 mm Hg or greater than 140 mm Hg.
- Diastolic blood pressure is less than 60 mm Hg or greater than 90 mmHg.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to the first vaccination or expects to receive an experimental agent, other than from participation in this study, during the 13-month study period.
- Are participating or plan to participate in another clinical trial with a licensed product during the 13-month study period.
- Have any condition that would, in the opinion of the site principal investigator or appropriate sub-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 (does not apply to documented placebo recipients) or have a history of A/H5 infection prior to enrollment.
- Have known active HIV, Hepatitis B, or Hepatitis C infection.
- Have a history of alcohol or drug abuse in the last 5 years.
- Plan to travel outside the U.S. in the time between the first vaccination and 42 days following the first vaccination.
- Have a history of Guillain-Barré Syndrome.
- Have any condition that the site principal investigator or appropriate sub-investigator believes may interfere with successful completion of the study.
- Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination.
- Other than from participation in this study, received an experimental agent (vaccine, drug, biologic, device, blood product, or medication), since receipt of Dose 1, or expects to receive an experimental agent during the 13-month study period.
- Are participating/have participated, since receipt of Dose 1, or plan to participate in another clinical trial with a licensed product during the 13-month study period.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic), new diagnosis of an active malignancy, or is immunosuppressed as a result of an underlying illness or treatment since receipt of Dose 1.
- Use of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose or equivalent dose of other glucocorticoids); or high-dose inhaled steroids (high dose defined as > 800 mcg/day of beclomethasone dipropionate or equivalent); or systemic corticosteroids of any dose for 2 weeks or more in total since receipt of Dose 1.Those patients who have received >/= 6-13 days of steroids, within the past 21 days will require at least 14 days off of steroids prior to administration of the second dose of vaccine - see Section 10.3.3. Under 6 days of steroids, no deferral of the second dose of study vaccine is needed.
- Received immunoglobulin or other blood products (with exception of Rho D immune globulin) since receipt of Dose 1.
- Received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to the second vaccination or plan receipt of such vaccines within 21 days following the second vaccination. This is inclusive of licensed seasonal influenza vaccines.
- Have a new diagnosis of chronic medical disease or chronic medical condition since receipt of Dose 1 that, in the opinion of the site principal investigator or appropriate sub-investigator, would render vaccination unsafe, would interfere with the evaluation of responses or is not generally seen in "normal, healthy subjects".
- Received systemic, prescription medications for the treatment of chronic medical conditions, unless such use is on a PRN (as needed) basis only since receipt of Dose 1. Non-PRN use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Note: Topical, nasal, and inhaled medications; vitamins; and contraceptives are also permitted
- Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to second vaccination, or planned medication with analgesic or antipyretic in the week following second vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged.
- Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others since receipt of Dose 1.
- New occurrence or new awareness of Guillain-Barré Syndrome since receipt of Dose 1.
- Any unresolved or continuing solicited or unsolicited Grade 2 or greater severity adverse events, including reactogenicity events, that have occurred since receipt of Dose 1 without a clear, alternative etiology. Unresolved or continuing Grade 1 adverse events are permissible unless, in the opinion of the site principal investigator or appropriate sub-investigator, they would render vaccination unsafe, would interfere with the evaluation of responses or are not generally seen in "normal, healthy subjects".
- Grade 2 or greater severity clinical safety lab values (according to the toxicity table, Section 11.1.1.2) that do not return to Grade 1 or less prior to the second vaccination. If the clinical safety lab values return to Grade 1 or less, vaccination should be rescheduled within the acceptable window for the second vaccination - see Section 10.3.3. Subjects who experienced a Grade 3 or above clinical safety laboratory adverse event since receipt of Dose 1 should be excluded from receipt of second vaccination. Subjects who had a Grade 3 or above clinical safety laboratory adverse event prior to first vaccination will be evaluated by the site principal investigator and DMID Medical Monitor to determine receipt of second vaccination.
- Have an acute illness, including an oral temperature greater than or equal to 100.4 degrees Fahrenheit, within 3 days prior to the second vaccination. Vaccination of subjects should be deferred until acute illness, including an oral temperature greater than or equal to 100.4 degrees Fahrenheit, has resolved. If resolution occurs, vaccination should be rescheduled within the acceptable window for the second vaccination - see Section 10.3.3.
- Emergence of Grade 2 or greater severity signs or symptoms since receipt of Dose 1 that could confound or confuse assessment of vaccine reactogenicity.
- Any new clinical findings since receipt of Dose 1, which in the opinion of the site principal investigator or appropriate sub-investigator, would compromise the safety of the subject or would interfere with the evaluation of responses or successful completion of the study.
- Plan to travel outside the U.S. in the time between the second vaccination and 21 days following the second vaccination.
- Subject refuses further vaccination. Subjects who do not receive the second vaccination will be asked to return for safety assessments and for scheduled venous blood sample collections for clinical safety laboratory and immunogenicity evaluations and will be followed for the duration of the study - see the protocol-specific Manual of Procedures (MOP) for further details.
- Subject withdraws consent. The subject may withdraw their consent for study participation at any time and for any reason, without penalty.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory Children's Center - Division of Pediatric Infectious Diseases
Atlanta, Georgia, 30322
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3026
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, 30030-2517
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, 52242-1009
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without MF59 Adjuvant
Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.
Read the detailed description
This is a randomized, double-blinded, controlled, Phase I study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at different dosage levels (3.75, 7.5 or 15 mcg) given with the MF59 adjuvant manufactured by Novartis or PBS diluent.
- Conditions
- Influenza
- Being tested
- Phosphate Buffered Saline (PBS) diluent, MF59 Adjuvant, H5N1 Antigen
- Keywords
- H5N1, vaccine, influenza
- 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.
Phosphate Buffered Saline (PBS) diluentOther
Placebo/diluent provided be sanofi pasteur
MF59 AdjuvantDrug
Adjuvant/diluent manufactured by Novartis
H5N1 AntigenBiological
Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, , administered at 3.75, 7.5, or 15mcg, with either MF59 adjuvant or PBS.
| Study group | Role | What they receive |
|---|---|---|
| Group 5 | Placebo comparator | Two doses of sanofi H5N1 antigen 7.5 mcg plus PBS diluent Receives: Other: Phosphate Buffered Saline (PBS) diluent; Biological: H5N1 Antigen |
| Group 4 | Placebo comparator | Two doses of sanofi H5N1 antigen 3.75 mcg plus Phosphate Buffered Saline (PBS) diluent Receives: Other: Phosphate Buffered Saline (PBS) diluent; Biological: H5N1 Antigen |
| Group 3 | Experimental | Two doses of sanofi H5N1 antigen 15 mcg plus Novartis MF59 adjuvant Receives: Drug: MF59 Adjuvant; Biological: H5N1 Antigen |
| Group 2 | Experimental | Two doses of sanofi H5N1 antigen 7.5 mcg plus Novartis MF59 adjuvant Receives: Drug: MF59 Adjuvant; Biological: H5N1 Antigen |
| Group 1 | Experimental | Two doses of sanofi H5N1 antigen 3.75 mcg plus Novartis MF59 adjuvant Receives: Drug: MF59 Adjuvant; Biological: H5N1 Antigen |
| Group 6 | Placebo comparator | Two doses of sanofi H5N1 antigen 15 mcg plus PBS diluent Receives: Other: Phosphate Buffered Saline (PBS) diluent; Biological: H5N1 Antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: Geometric mean titer (GMT) of HAI antibody, subjects with HAI antibody titer 1:40 or greater, and frequency of 4-fold or greater HAI antibody increase against A/H5N1 vaccine in each group 21 days following 2nd vaccine dose (approx Day 42)
Measured: Day 42
Safety/Tolerability: Occurrence of vaccine-associated serious adverse events (SAEs) and clinical safety laboratory adverse events (AEs) from the time of first vaccination through 13 months after the first vaccination.
Measured: From time of 1st vaccination through 13 months
Safety/Tolerability: Occurrence of solicited local and systemic reactogenicity in the 8 days (Day 0-7) after each vaccination.
Measured: Day 0 through Day 7 after each vaccination
Secondary outcomes (1)
GMT of neutralizing antibody (NA), proportion of subjects with a serum NA titer of 1:40 or greater, and frequency of 4-fold or greater increases of NA against A/H5N1 virus vaccine in each group 21 days following 2nd dose of vaccine (approximately Day 42)
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317745
- Sponsor's protocol ID
- 10-0016
- Other IDs
- N01AI80005C
- Status last verified
- Aug 2012
- First submitted
- 16 Mar 2011
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without MF59 Adjuvant
- ClinicalTrials.gov ID
- NCT01317745
- Acronym / sponsor ID
- 10-0016
- Conditions
- Influenza
- Keywords
- H5N1, vaccine, influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Mar 2011 (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.
Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.
Detailed description
This is a randomized, double-blinded, controlled, Phase I study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at different dosage levels (3.75, 7.5 or 15 mcg) given with the MF59 adjuvant manufactured by Novartis or PBS diluent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 5 | Placebo comparator | Other: Phosphate Buffered Saline (PBS) diluent, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 7.5 mcg plus PBS diluent |
| Group 4 | Placebo comparator | Other: Phosphate Buffered Saline (PBS) diluent, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 3.75 mcg plus Phosphate Buffered Saline (PBS) diluent |
| Group 3 | Experimental | Drug: MF59 Adjuvant, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 15 mcg plus Novartis MF59 adjuvant |
| Group 2 | Experimental | Drug: MF59 Adjuvant, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 7.5 mcg plus Novartis MF59 adjuvant |
| Group 1 | Experimental | Drug: MF59 Adjuvant, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 3.75 mcg plus Novartis MF59 adjuvant |
| Group 6 | Placebo comparator | Other: Phosphate Buffered Saline (PBS) diluent, Biological: H5N1 AntigenTwo doses of sanofi H5N1 antigen 15 mcg plus PBS diluent |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are males or non-pregnant females between the ages of 18 and 49 years, inclusive.
- Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for >/=1 year) must agree to practice adequate contraception (that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods) during the study for at least 30 days following the last vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
- Are in good health, as determined by vital signs (oral temp, pulse and blood pressure), medical history and complete physical examination (without genital and rectal exam) to ensure no existing chronic medical diagnoses or conditions are present.
- ESR less than 30 mm per hour.
- For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the first vaccination.
Key exclusion criteria (46 listed)
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal and chicken protein), or allergy to squalene-based adjuvants.
- Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination.
- Have long term use (defined as taken for 2 weeks or more in total at any time during the past 2 months) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids); or high-dose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent); or systemic corticosteroids of any dose within the past 4 weeks.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
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 |
|---|---|---|
| Phosphate Buffered Saline (PBS) diluentPlacebo/diluent provided be sanofi pasteur | Other | Group 4, Group 5, Group 6 |
| MF59 AdjuvantAdjuvant/diluent manufactured by Novartis | Drug | Group 1, Group 2, Group 3 |
| H5N1 AntigenSubvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, , administered at 3.75, 7.5, or 15mcg, with either MF59 adjuvant or PBS. | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Immunogenicity: Geometric mean titer (GMT) of HAI antibody, subjects with HAI antibody titer 1:40 or greater, and frequency of 4-fold or greater HAI antibody increase against A/H5N1 vaccine in each group 21 days following 2nd vaccine dose (approx Day 42)
Time frame: Day 42
Safety/Tolerability: Occurrence of vaccine-associated serious adverse events (SAEs) and clinical safety laboratory adverse events (AEs) from the time of first vaccination through 13 months after the first vaccination.
Time frame: From time of 1st vaccination through 13 months
Safety/Tolerability: Occurrence of solicited local and systemic reactogenicity in the 8 days (Day 0-7) after each vaccination.
Time frame: Day 0 through Day 7 after each vaccination
1 secondary outcome
GMT of neutralizing antibody (NA), proportion of subjects with a serum NA titer of 1:40 or greater, and frequency of 4-fold or greater increases of NA against A/H5N1 virus vaccine in each group 21 days following 2nd dose of vaccine (approximately Day 42)
Time frame: Day 42
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 25 Jan 2013.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phosphate Buffered Saline (PBS) diluent, MF59 Adjuvant and H5N1 Antigen in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 9 inclusion and 46 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 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 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.
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?
Immunogenicity: Geometric mean titer (GMT) of HAI antibody, subjects with HAI antibody titer 1:40 or greater, and frequency of 4-fold or greater HAI antibody increase against A/H5N1 vaccine in each group 21 days following 2nd vaccine dose (approx Day 42) (time frame: Day 42). 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?
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 25 Jan 2013.