FLUAD® vs. Fluzone® High-Dose Study

March 4, 2021 updated by: Duke University

Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults

The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Full Analysis Population 1: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary.

Full Analysis Population 2: Defined as all subjects who are randomized and vaccinated.

Immunogenicity Population: Defined as subjects who received vaccine, provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
757

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30333
        • Centers for Disease Control and Prevention
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Persons aged ≥65 years, living in the community
  2. Intention of receiving IIV vaccine based on ACIP-CDC guidelines
  3. Willing to provide written informed consent prior to initiation of any study procedures
  4. Able to speak English
  5. Able and willing to complete baseline assessments and questionnaires, and to allow information to be collected from their electronic medical record
  6. Able and willing to complete post-vaccine assessments and questionnaires independently or with assistance
  7. Able and willing to have blood drawn for the study
  8. Able and willing to return in about one month for a follow-up visit including completing questionnaires and having another blood test
  9. Access to and ability to use a phone, independently or with assistance
  10. Adequate vision and motor skills to complete the diary form independently or with assistance.
  11. Not living in a skilled nursing facility/nursing home/long term acute care facility

Exclusion Criteria:

  1. IIV receipt during the current influenza season prior to study enrollment

  2. Enrolled in this study during the 2017-18 (Year 1) influenza season

    Note: Year 1 study participants will only be enrolled in Year 2 if they are participating in the sub-study on repeat vaccination

  3. Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 12 months.

  4. Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy*

    *Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 12 months)

  5. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection
  6. History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration (temporary deferral)

  7. Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component*, including egg protein; or a latex allergy

    *Formaldehyde, Octylphenol ethoxylate, neomycin, kanamycin, barium, cetyltrimethlyammonium bromide (CTAB)

  8. Any history of Guillain-Barré syndrome
  9. Mild to severe dementia as determined by the Mini-Cog tool and the Rowland Universal Dementia Assessment Scale (RUDAS)
  10. Substance use that could interfere with study compliance
  11. Receipt of any inactivated licensed vaccine within 2 weeks, or live attenuated licensed vaccine within 4 weeks prior to enrollment in this study, or planning receipt of any vaccines during the 42-days post-vaccination period (including pneumococcal vaccines)
  12. Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 30 days following vaccine receipt.
  13. Hearing loss determined by the investigators to prevent successful communication over the phone
  14. Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
  15. Anyone who is a relative or subordinate of any research study personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Adjuvanted influenza vaccine (FLUAD®)
In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.
Biological: FLUAD®
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Other Names:
  • Adjuvanted influenza vaccine
Active Comparator: High-dose influenza vaccine (Fluzone® HD)
In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.
Biological: Fluzone® High-Dose
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Other Names:
  • High-dose influenza vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups.
Days 1 through 8 post-vaccination
Number of Participants With Adverse Events of Clinical Interest, Population 2
Time Frame: 42 days post-vaccination and compared between the two groups.
The frequency and descriptions of adverse events of clinical interest observed in the two treatment groups.
42 days post-vaccination and compared between the two groups.
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Time Frame: 42 days post-vaccination and compared between the two groups.

The frequency and descriptions of serious adverse events observed in the two treatment groups.

No analytical analysis was completed.
42 days post-vaccination and compared between the two groups.
Number of Participants With H3N2 HAI Seroconversion
Time Frame: 29 days post-vaccination
H3N2 hemagglutination inhibition assay (HAI) seroconversion: The proportion of subjects achieving H3N2 seroconversion at day 29 (an HAI titer > 1:40 at day 29 if the baseline titer is < 1:10 or a four-fold rise in HAI titer if the baseline titer is > 1:10) in the respective season's vaccine
29 days post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of local reactions within the first week post-vaccination in both treatment groups.
Days 1 through 8 post-vaccination
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Days 1 through 8 post-vaccination
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Days 1 through 8 post-vaccination
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of systemic reactions within the first week post-vaccination in both treatment groups.
Days 1 through 8 post-vaccination
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Days 1 through 8 post-vaccination
Number of Participants With System Reactions - Ages 80 +, Population 1
Time Frame: Days 1 through 8 post-vaccination
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Days 1 through 8 post-vaccination
Quality of Life - Late Life Function & Disability Instrument - Full Population
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes.

The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1).

The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes.

The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1).

The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the Late Life Function & Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes.

The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1).

The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L -Full Population
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only).

Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L - Ages 65 - 79
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only).

Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ-5D-5L - Ages 80 +
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only)

Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS -Full Population
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only).

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS - Ages 65 - 79
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only).

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Quality of Life - EQ VAS - Ages 80 +
Time Frame: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)

Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only).

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)
Seroconversion - 65 and Older
Time Frame: Day 29 (28 days post-vaccination)
The proportion of subjects achieving seroconversion at day 29 (an HAI titer > 1:40 at day 29 if the baseline titer is < 1:10 or a four-fold rise in HAI titer if the baseline titer
Day 29 (28 days post-vaccination)
Seroprotection - 65 and Older
Time Frame: Day 29 (28 days post-vaccination)
Proportion of subjects with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - 65 and Older
Time Frame: Day 29 (28 days post-vaccination)
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine
Day 29 (28 days post-vaccination)
Seroconversion - Ages 65-79
Time Frame: Day 29 (28 days post-vaccination)
The proportion of subjects aged 65-79 achieving seroconversion at day 29 (an HAI titer > 1:40 at day 29 if the baseline titer is < 1:10 or a four-fold rise in HAI titer if the baseline titer
Day 29 (28 days post-vaccination)
Seroconversion - Ages 80 and Older
Time Frame: Day 29 (28 days post-vaccination)
The proportion of subjects ages 80 and older achieving seroconversion at day 29 (an HAI titer > 1:40 at day 29 if the baseline titer is < 1:10 or a four-fold rise in HAI titer if the baseline titer
Day 29 (28 days post-vaccination)
Seroprotection - Ages 65-79
Time Frame: Day 29 (28 days post-vaccination)
Proportion of subjects ages 65-79 with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Day 29 (28 days post-vaccination)
Seroprotection - Ages 80 and Older
Time Frame: Day 29 (28 days post-vaccination)
Proportion of subjects ages 80 and older with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - Ages 65-79
Time Frame: Day 29 (28 days post-vaccination)
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 65-79
Day 29 (28 days post-vaccination)
Geometric Mean HAI Titer - Ages 80 and Older
Time Frame: Day 29 (28 days post-vaccination)
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 80 and older
Day 29 (28 days post-vaccination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Medical Center
Centers for Disease Control and Prevention
Children's Hospital Medical Center, Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Schmader, MD, Duke University
  • Principal Investigator: Elizabeth Barnett, MD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00083845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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