InfluenzaPhase 2NCT00253734
Immunogenicity and Safety of Different Doses of Fluzone® Influenza
A Phase 2 study testing Fluzone® (IM) and Fluzone® in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. 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?
- Fluzone® (IM) and Fluzone®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2006
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is healthy, as determined by medical history and clinical assessment before entering the study.
- Between the ages of 18 and 49 (greater than or equal to 18 and less than 50)
- Provides written informed consent
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, menopausal or surgically sterile or negative serum/urine pregnancy test within 24 hours prior to the time of vaccination.
Who cannot join
- Breast-feeding or pregnant.
- History of receiving 2003-2004, 2004-2005 or 2005-2006 influenza vaccine.
- Known allergy to eggs or other components of the vaccine (e.g., 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-Barre Syndrome.
- Immunosuppression as a result of underlying illness or treatment.
Show all 23Show fewer
- Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
- 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 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.
- 13. 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 28 days (prior to visit 2) following trial vaccination.
- Subject is enrolled in a conflicting clinical trial.
- Thrombocytopenia or bleeding disorder or therapy contraindicating IM vaccination.
- Female planning on becoming pregnant within one month of vaccination.
- Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
- Febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees Fahrenheit) within 72 hours prior to enrollment.
- Receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination.
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant.
- Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site.
- History of drug abuse or alcohol abuse in the five years prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone® in Healthy Adults
The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.
Read the detailed description
This study is a randomized, prospective, active-controlled, single-center, open label, dose-ranging clinical trial of TIV (Fluzone®) administered to healthy 18-to-49 year old adults who did not receive 2003-2004, 2004-2005 and 2005-2006 influenza vaccine. Subjects will be randomized to one of 7 groups (4 intramuscular and 3 intradermal) to compare the immunogenicity and safety of different concentrations of the standard Fluzone® administered intradermally using the Mantoux technique to that of standard Fluzone® administered intramuscularly. The primary objective of the study is to compare the immunogenicity of injected Fluzone® across different dose levels and different routes of administration. The secondary objectives are to describe the number and proportions of subjects in each group experiencing any injection site or systemic symptoms and the proportion of subjects who experience moderate-to-severe symptoms post vaccination. Approximately 31 subjects per group (217 in total) will be enrolled with each group determined by dose and route of administration of vaccines. Subjects will be observed in the clinic for at least 30 minutes after immunization and will maintain a memory aid to record daily oral temperature and any systemic and local reactions for 7 days after the day of immunization. Subjects will be contacted by phone between 8 to 12 days after immunization to review their 7-day memory aid, including the assessment of their recorded daily oral temperature, any local or systemic reactions, and the occurrence of any other AEs and SAEs. Subjects will return at 28 (+/- 3) days after immunization to assess the occurrence of unsolicited AEs and SAEs and complete an acceptability and functional skill questionnaire. Serum for immunogenicity evaluations will be obtained prior to the first vaccination and approximately 28 (+/- 3) days post vaccination. The 2005-2006 formulation will be used for all seven groups.
- Conditions
- Influenza
- Being tested
- Fluzone® (IM), Fluzone®
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® (IM)Biological
15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
Fluzone®Biological
9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
| Study group | Role | What they receive |
|---|---|---|
| 4 | Active comparator | 31 subjects to receive 15 mcg of TIV administered intramuscularly. Receives: Biological: Fluzone® (IM) |
| 2 | Experimental | 31 subjects to receive 6 mcg of TIV administered intradermally. Receives: Biological: Fluzone® |
| 1 | Experimental | 31 subjects to receive 9 mcg of TIV administered intradermally. Receives: Biological: Fluzone® |
| 3 | Experimental | 31 subjects to receive 3 mcg of TIV administered intradermally. Receives: Biological: Fluzone® |
| 5 | Active comparator | 31 subjects to receive 9 mcg of TIV administered intramuscularly. Receives: Biological: Fluzone® (IM) |
| 7 | Active comparator | 31 subjects to receive 3 mcg of TIV administered intramuscularly. Receives: Biological: Fluzone® (IM) |
| 6 | Active comparator | 31 subjects to receive 6 mcg of TIV administered intramuscularly. Receives: Biological: Fluzone® (IM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity evaluated by haemagglutination-inhibition assay (HAI).
Measured: Blood sampled at day 28 +/- 3 days post vaccination.
Secondary outcomes (1)
Safety: solicited adverse events (AE)-reactogenicity following each vaccination (local and systemic reactions); unsolicited adverse events, and serious AEs.
Measured: Adverse events-reactogenicity following each vaccination. Unsolicited AEs through day 28 +/- 3. Serious AEs occurring during the length of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2006
- Study completionNov 2006
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253734
- Sponsor's protocol ID
- 05-0109
- Status last verified
- Jul 2008
- First submitted
- 11 Nov 2005
- Last updated
- 3 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone® in Healthy Adults
- ClinicalTrials.gov ID
- NCT00253734
- Acronym / sponsor ID
- 05-0109
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.
Detailed description
This study is a randomized, prospective, active-controlled, single-center, open label, dose-ranging clinical trial of TIV (Fluzone®) administered to healthy 18-to-49 year old adults who did not receive 2003-2004, 2004-2005 and 2005-2006 influenza vaccine. Subjects will be randomized to one of 7 groups (4 intramuscular and 3 intradermal) to compare the immunogenicity and safety of different concentrations of the standard Fluzone® administered intradermally using the Mantoux technique to that of standard Fluzone® administered intramuscularly. The primary objective of the study is to compare the immunogenicity of injected Fluzone® across different dose levels and different routes of administration. The secondary objectives are to describe the number and proportions of subjects in each group experiencing any injection site or systemic symptoms and the proportion of subjects who experience moderate-to-severe symptoms post vaccination. Approximately 31 subjects per group (217 in total) will be enrolled with each group determined by dose and route of administration of vaccines. Subjects will be observed in the clinic for at least 30 minutes after immunization and will maintain a memory aid to record daily oral temperature and any systemic and local reactions for 7 days after the day of immunization. Subjects will be contacted by phone between 8 to 12 days after immunization to review their 7-day memory aid, including the assessment of their recorded daily oral temperature, any local or systemic reactions, and the occurrence of any other AEs and SAEs. Subjects will return at 28 (+/- 3) days after immunization to assess the occurrence of unsolicited AEs and SAEs and complete an acceptability and functional skill questionnaire. Serum for immunogenicity evaluations will be obtained prior to the first vaccination and approximately 28 (+/- 3) days post vaccination. The 2005-2006 formulation will be used for all seven groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 4 | Active comparator | Biological: Fluzone® (IM)31 subjects to receive 15 mcg of TIV administered intramuscularly. |
| 2 | Experimental | Biological: Fluzone®31 subjects to receive 6 mcg of TIV administered intradermally. |
| 1 | Experimental | Biological: Fluzone®31 subjects to receive 9 mcg of TIV administered intradermally. |
| 3 | Experimental | Biological: Fluzone®31 subjects to receive 3 mcg of TIV administered intradermally. |
| 5 | Active comparator | Biological: Fluzone® (IM)31 subjects to receive 9 mcg of TIV administered intramuscularly. |
| 7 | Active comparator | Biological: Fluzone® (IM)31 subjects to receive 3 mcg of TIV administered intramuscularly. |
| 6 | Active comparator | Biological: Fluzone® (IM)31 subjects to receive 6 mcg of TIV administered intramuscularly. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is healthy, as determined by medical history and clinical assessment before entering the study.
- Between the ages of 18 and 49 (greater than or equal to 18 and less than 50)
- Provides written informed consent
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, menopausal or surgically sterile or negative serum/urine pregnancy test within 24 hours prior to the time of vaccination.
Key exclusion criteria (23 listed)
- Breast-feeding or pregnant.
- History of receiving 2003-2004, 2004-2005 or 2005-2006 influenza vaccine.
- Known allergy to eggs or other components of the vaccine (e.g., 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-Barre Syndrome.
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 |
|---|---|---|
| Fluzone® (IM)15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route. | Biological | 4, 5, 6, 7 |
| Fluzone®9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique). | Biological | 1, 2, 3 |
Primary outcome
Immunogenicity evaluated by haemagglutination-inhibition assay (HAI).
Time frame: Blood sampled at day 28 +/- 3 days post vaccination.
1 secondary outcome
Safety: solicited adverse events (AE)-reactogenicity following each vaccination (local and systemic reactions); unsolicited adverse events, and serious AEs.
Time frame: Adverse events-reactogenicity following each vaccination. Unsolicited AEs through day 28 +/- 3. Serious AEs occurring during the length of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzone® (IM) and Fluzone® in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Immunogenicity evaluated by haemagglutination-inhibition assay (HAI). (time frame: Blood sampled at day 28 +/- 3 days post vaccination.). 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 3 Jun 2013.