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InfluenzaPhase 2NCT00115531

Eldery High Dose TIV 2005

A Phase 2 study testing Trivalent inactivated influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Trivalent inactivated influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
5 sitesUnited States
Study dates
Apr 2005to Nov 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for study participation:
  • Ambulatory medically stable persons >= 65 years of age on the date of vaccination
  • Provides written informed consent and will be available for all study visits
  • Able to understand and comply with planned study procedures
  • Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound. Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs must be controlled with medical therapy. Subjects with acute febrile illnesses [oral temperature equal to or exceeding 99.5ºF (37.5ºC)] will be deferred until 3 days after illness resolution.

Who cannot join

  • Subjects must not meet any of the following exclusion criteria in order to be eligible for participation in this study:
  • Known allergy to eggs or other components of the vaccine (eg, thimerosal);
  • History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances;
  • History of Guillain-Barré Syndrome;
  • Immunosuppression as a result of underlying illness or treatment;
  • Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (> 800 µg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination;
Show all 15Show fewer
  • Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination;
  • Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy);
  • Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus;
  • Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine;
  • Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine;
  • Receipt of immunoglobulin or other blood product within 3 months prior to enrollment;
  • Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 1 month (prior to visit 2) following trial vaccination;
  • Subject is enrolled in a conflicting clinical trial;
  • Thrombocytopenia or bleeding disorder or therapy contraindicating IM vaccination.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Iowa - Vaccine Research & Education Unit

    Iowa City, Iowa, 52242-2600

  • Saint Louis University

    St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: Comparisons of the Reactogenicity and Immunogenicity in Ambulatory Elderly Subjects of a Standard-Dose Fluzone® (15 µg HA/Virus Strain) and a High-Dose (60 µg HA/Virus Strain) of a Trivalent Inactivated Influenza Virus Vaccine

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection.

Read the detailed description

Influenza is a common respiratory infection caused by several related viruses. Epidemics of influenza occur each winter and are responsible for an average of about 36,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from chronic diseases, particularly of the lungs and the heart. Current influenza virus vaccines protect elderly persons against influenza, but not as well as desired. One consideration for trying to increase protection is to increase the vaccine dose, but there is some concern that increasing the dose may increase reactions to the vaccine (such as sore arm, aches, or fever). One of the vaccine manufacturers has prepared an experimental influenza virus vaccine with a dose that is higher than the currently used dose. A previous study with the same high dose of the vaccine showed that it was well tolerated with only increased reactions at the injection site compared to the usual vaccine. Since the study, the high-dose vaccine has also been made without preservative (thimerosal) and gelatin, which are in the standard vaccine. It is expected that this vaccine can be given with little reaction, but this needs to be determined. It also needs to be shown whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of influenza vaccine. The purpose of this research is to compare reactions and antibody responses following standard flu vaccine to those following the experimental vaccine. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection. This study is linked to DMID protocol 05-0028.

Conditions
Influenza
Being tested
Trivalent inactivated influenza vaccine
Keywords
Elderly, influenza, vaccine, parent protocol
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trivalent inactivated influenza vaccineBiological

    Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.

  • Trivalent inactivated influenza vaccineBiological

    High Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.

Study groups in NCT00115531
Study groupRoleWhat they receive
Arm 1ExperimentalStandard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.
Receives: Biological: Trivalent inactivated influenza vaccine
Arm 2ExperimentalHigh Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.
Receives: Biological: Trivalent inactivated influenza vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2005 (estimated)
  2. Study startApr 2005
  3. Study completionNov 2005

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115531
Sponsor's protocol ID
04-100
Status last verified
Feb 2007
First submitted
22 Jun 2005
Last updated
19 Dec 2014
Results posted
No

Publications

  • Chen WH, Cross AS, Edelman R, Sztein MB, Blackwelder WC, Pasetti MF. Antibody and Th1-type cell-mediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine. 2011 Apr 5;29(16):2865-73. doi: 10.1016/j.vaccine.2011.02.017. Epub 2011 Feb 23.

    PubMed 21352939

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trivalent inactivated influenza vaccine 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 5 inclusion and 15 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 19 Dec 2014. 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. 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 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115531, 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 19 Dec 2014.

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