InfluenzaPhase 2NCT00283283

Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine

A Phase 2 study testing Fluzone® (Aventis Pasteur inactivated influenza vaccine) in people with Influenza, run by U.S. Army Medical Research and Development Command at 2 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

This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,316 participants
Where: 2 sitesUnited States
Study dates: Nov 2004to May 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to understand and comply with all study procedures including availability for all study visits and follow up surveys within 6 months following study enrollment.
DEERS eligible beneficiaries eligible for influenza vaccination and able to give informed consent.
Age 18-49
Patients presenting to travel clinic with no exclusion criteria;
Household contacts and out-of-home caretakers of infants from 6-23 months of age;
Hospital and/or employees providing service to the public who are not eligible for the post-October 5th recommendations for priority immunization;

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DOD employees eligible for influenza vaccination prior to October 5th but excluded in the post October 5th guidelines;
People living in dormitories or under other crowded conditions, to prevent outbreaks;
Ages 50-64 years of age who are not eligible for the post-October 5th recommendations for priority immunization and with no standard of care contraindications to vaccination.
Eligible in the Department of Defense for influenza vaccination

Who cannot join

all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy);
adults aged >65 years;
persons aged 2-64 years with underlying chronic medical conditions:
includes persons with chronic cardiac or pulmonary disease, diabetes mellitus, hemoglobinopathy, or immunosuppressive illness;
any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of response.
use of experimental vaccines or medications within 30 days of study entry;

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receipt of parenteral immunoglobulin within 60 days of study entry;
all women who will be pregnant during the influenza season;
residents of nursing homes and long-term care facilities;
health-care workers involved in direct patient care and included in DOD priority 1; and;
military recruits;
out-of-home caregivers and household contacts of children aged <6 months.
Anyone with clinical contraindications for receiving the inactivated influenza vaccine such as a history of severe allergic reaction to prior influenza vaccinations, severe allergy to egg and/or egg proteins and gelatin.
DOD Priority 1: Deployed or deploying (with orders) service members and others designated as critical to national defense.
DOD Priority 2: Medically high risk in accordance with ACIP guidelines (includes health-care workers with direct patient contact)
Any acute or chronic condition that, in the opinion of the investigator or her provider designee would render vaccination unsafe or interfere with the evaluation of the response.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pentagon
Washington D.C., District of Columbia, 20050
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

Official title: Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose

This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.

Read the detailed description

This was a Phase II prospective, single-blind to dose, randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®, 2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines, were divided into 8 strata based on age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose (0.25mL) Fluzone® or full-dose (0.5mL) Fluzone® by intramuscular injection into the deltoid muscle.

Conditions: Influenza
Being tested: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
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® (Aventis Pasteur inactivated influenza vaccine)Biological
A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002

Study groups in NCT00283283
Study group	Role	What they receive
Male, Age 18 -49, Full Dose	Experimental	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Male, Age 50 -64, Half Dose	Experimental	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Female, Age 18 - 49, Full Dose	Experimental	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Female, Age 18 - 49, Half Dose	Experimental	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Male, Age 18 - 49, Half Dose	Experimental	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Male, Age 50 -64, Full Dose	Experimental	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Female, Age 50 -64, Full Dose	Experimental	0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Female, Age 50 -64, Half Dose	Experimental	0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Receives: Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Immune Response: Age 18-49
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Measured: 21 days post-vaccincation
Immune Response: Age 50-64
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64
Measured: 21 days post-vaccincation

Secondary outcomes (1)

Medical Events: Unsolicited Adverse Events
Assessed through following subjects' recording of oral body temperature, completion of a 21-day symptom diary; subjects' completion of longer-term follow-up surveys to track respiratory symptoms; and a review of the Defense Medical Surveillance System (DMSS) hospitalization and outpatient medical visits database in order to track ICD-9 codes relevant to flu-like illness.
Measured: 3 - 6 months following vaccination

Timeline

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

Nov 2004May 2006

First posted27 Jan 2006 (estimated)
Study startNov 2004
Primary completionNov 2004
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
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: Single blind
Who is masked: Participant
Enrolment: 1,316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00283283
Sponsor's protocol ID: A-13205
Status last verified: Feb 2021
First submitted: 24 Jan 2006
Last updated: 12 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ; Walter Reed Health Care System Influenza Vaccine Consortium. Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Arch Intern Med. 2008 Dec 8;168(22):2405-14. doi: 10.1001/archinternmed.2008.513.
PubMed 19064822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose
ClinicalTrials.gov ID: NCT00283283
Acronym / sponsor ID: A-13205
Conditions: Influenza
Keywords: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,316 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: Walter Reed Army Medical Center, United States Army Medical Materiel Development Activity, Centers for Disease Control and Prevention, Uniformed Services University of the Health Sciences, Walter Reed Army Institute of Research (WRAIR), U.S. Air Force Office of the Surgeon General
Study start: Nov 2004 (actual)
Primary completion: Nov 2004 (actual)
Study completion: May 2006 (actual)
First posted: 27 Jan 2006 (estimated)
Results: Posted 19 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Male, Age 18 -49, Full Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Male, Age 50 -64, Half Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Female, Age 18 - 49, Full Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 18 - 49, Half Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Male, Age 18 - 49, Half Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain
Male, Age 50 -64, Full Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 50 -64, Full Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain
Female, Age 50 -64, Half Dose	Experimental	Biological: Fluzone® (Aventis Pasteur inactivated influenza vaccine)0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Able to understand and comply with all study procedures including availability for all study visits and follow up surveys within 6 months following study enrollment.
DEERS eligible beneficiaries eligible for influenza vaccination and able to give informed consent.
Age 18-49
Ages 50-64 years of age who are not eligible for the post-October 5th recommendations for priority immunization and with no standard of care contraindications to vaccination.
Eligible in the Department of Defense for influenza vaccination

Key exclusion criteria (16 listed)

all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy);
adults aged >65 years;
persons aged 2-64 years with underlying chronic medical conditions:
use of experimental vaccines or medications within 30 days of study entry;
receipt of parenteral immunoglobulin within 60 days of study entry;

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® (Aventis Pasteur inactivated influenza vaccine)A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Biological	Female, Age 18 - 49, Full Dose, Female, Age 18 - 49, Half Dose, Female, Age 50 -64, Full Dose, Female, Age 50 -64, Half Dose, Male, Age 18 - 49, Half Dose, Male, Age 18 -49, Full Dose, Male, Age 50 -64, Full Dose, Male, Age 50 -64, Half Dose

Primary outcome

Immune Response: Age 18-49
Time frame: 21 days post-vaccincation
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Immune Response: Age 50-64
Time frame: 21 days post-vaccincation
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64

1 secondary outcome

Medical Events: Unsolicited Adverse Events
Time frame: 3 - 6 months following vaccination

Results and safety

Results posted to the registry on 19 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Dose, Age 18-49	274	274
Half Dose, Age 18-49	284	284
Full Dose, Age 50-64	280	280
Half Dose, Age 50-64	276	276

Primary outcome: Immune Response: Age 18-49

Time frame: 21 days post-vaccincation. Geometric mean (95% Confidence Interval). Unit: Anti-body response (GMT)

Measure	Age 18 - 49, Full Dose n = 274	Age 18 - 49, Half Dose n = 284
H1N1 - GMT	28.8 (25.2 to 32.8)	21.3 (18.9 to 24.0)
H3N2 - GMT	55.2 (48.7 to 62.5)	45.0 (39.7 to 50.9)
B - GMT	69.6 (61.4 to 78.9)	54.8 (49.1 to 61.2)

Population analysed: From the 1263 subjects enrolled, final analysis includes baseline re-vaccinated subs who fit all inc/exc criteria and whose serum specimens were usable. Data summarizes the differences in influenza strain specific serologic responses according to vaccine dose and age. Antibodies were measured by Hemagglutination Inhibition. GMT=Geometric Mean Titer

Primary outcome: Immune Response: Age 50-64

Time frame: 21 days post-vaccincation. Geometric mean (95% Confidence Interval). Unit: Anti-body response (GMT)

Measure	Age 50 - 64, Full Dose n = 280	Age 50 - 64, Half Dose n = 276
H1N1 - GMT	21.4 (18.6 to 24.7)	14.2 (12.7 to 15.9)
H3N2 - GMT	59.0 (51.4 to 67.8)	39.1 (34.3 to 44.6)
B - GMT	52.1 (45.5 to 59.8)	36.8 (32.4 to 41.9)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 - 6 months following vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Dose	2 of 554 (0.4%)	18 of 554 (3.2%)	0 of 554
Half Dose	1 of 556 (0.2%)	17 of 556 (3.1%)	0 of 556

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19064822Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ; Walter Reed Health Care System Influenza Vaccine Consortium. Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Arch Intern Med. 2008 Dec 8;168(22):2405-14. doi: 10.1001/archinternmed.2008.513.
Individual participant dataSharing planned: No

Related trials for Influenza

Active, not recruitingEarly Phase 1
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RecruitingPhase 1
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A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
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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.

Renata J Engler, M.D principal investigator

Walter Reed Army Medical Center

2 sites 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® (Aventis Pasteur inactivated influenza vaccine) in people with Influenza, run by U.S. Army Medical Research and Development Command at 2 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 10 inclusion and 16 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Immune Response: Age 18-49 (time frame: 21 days post-vaccincation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00283283, 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 12 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.