Influenza
Conditions
Keywords
Influenza
Brief summary
This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.
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.
Interventions
BIOLOGICALFluzone® (Aventis Pasteur inactivated influenza vaccine)
A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Sponsors
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
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Response: Age 18-49 | 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 | 21 days post-vaccincation | Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Events: Unsolicited Adverse Events | 3 - 6 months following vaccination | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Race/Ethnicity Baseline Measure | Enrollment Day | Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited at the Walter Reed Army Medical Center Allergy-Immunization Clinic, the Fort Belvoir DeWitt Allergy-Immunization Clinic and the Pentagon Health Clinic during the annual influenza immunization program.
Pre-assignment details
Enrollment was expanded to include subs with a history of flu vacs. From the originally enrolled subjects (1316), the final data analysis includes only members of the baseline re-vaccination population (1114).
Participants by arm
| Arm | Count |
|---|---|
| Full Dose, Age 18-49 Previously Vaccinated Subjects Receiving Full Dose Aged 18-49 Years | 274 |
| Half Dose, Age 18-49 Previously Vaccinated Subjects Receiving Half Dose Aged 18-49 Years | 284 |
| Full Dose, Age 50-64 Previously Vaccinated Subjects Receiving Full Dose Aged 50-64 Years | 280 |
| Half Dose, Age 50-64 Previously Vaccinated Subjects Receiving Half Dose Aged 50-64 Years | 276 |
| Total | 1,114 |
Baseline characteristics
| Characteristic | Full Dose, Age 18-49 | Half Dose, Age 18-49 | Full Dose, Age 50-64 | Half Dose, Age 50-64 | Total |
|---|---|---|---|---|---|
| Age, Customized | 274 years | 284 years | 280 years | 276 years | 1114 years |
| Region of Enrollment United States | 274 participants | 284 participants | 280 participants | 276 participants | 1114 participants |
| Sex: Female, Male Female | 126 Participants | 121 Participants | 119 Participants | 118 Participants | 484 Participants |
| Sex: Female, Male Male | 148 Participants | 163 Participants | 161 Participants | 158 Participants | 630 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 554 | 0 / 556 |
| other Total, other adverse events | 18 / 554 | 17 / 556 |
| serious Total, serious adverse events | 2 / 554 | 1 / 556 |
Outcome results
Primary
Immune Response: Age 18-49
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49
Time frame: 21 days post-vaccincation
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 18 - 49, Full Dose | Immune Response: Age 18-49 | H1N1 - GMT | 28.8 Anti-body response (GMT) |
| Age 18 - 49, Full Dose | Immune Response: Age 18-49 | H3N2 - GMT | 55.2 Anti-body response (GMT) |
| Age 18 - 49, Full Dose | Immune Response: Age 18-49 | B - GMT | 69.6 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 18-49 | H1N1 - GMT | 21.3 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 18-49 | H3N2 - GMT | 45.0 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 18-49 | B - GMT | 54.8 Anti-body response (GMT) |
Primary
Immune Response: Age 50-64
Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64
Time frame: 21 days post-vaccincation
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 18 - 49, Full Dose | Immune Response: Age 50-64 | H1N1 - GMT | 21.4 Anti-body response (GMT) |
| Age 18 - 49, Full Dose | Immune Response: Age 50-64 | H3N2 - GMT | 59.0 Anti-body response (GMT) |
| Age 18 - 49, Full Dose | Immune Response: Age 50-64 | B - GMT | 52.1 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 50-64 | H1N1 - GMT | 14.2 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 50-64 | H3N2 - GMT | 39.1 Anti-body response (GMT) |
| Age 18 - 49, Half Dose | Immune Response: Age 50-64 | B - GMT | 36.8 Anti-body response (GMT) |
Secondary
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.
Time frame: 3 - 6 months following vaccination
Population: Of the original population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in the this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Respiratory System | 10 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Skin and Appendages | 14 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Body as a Whole | 0 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Urogenital System | 0 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Hematological and Lymphatic System | 2 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Symptions in Arm Given Shot | 13 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Headache | 0 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Digestive Sytem | 12 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Special Senses | 2 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Musculoskeletal System | 6 Adverse events |
| Age 18 - 49, Full Dose | Medical Events: Unsolicited Adverse Events | Cardiovascular System | 2 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Musculoskeletal System | 5 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Skin and Appendages | 8 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Respiratory System | 18 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Cardiovascular System | 2 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Body as a Whole | 6 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Symptions in Arm Given Shot | 1 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Digestive Sytem | 3 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Headache | 2 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Urogenital System | 4 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Hematological and Lymphatic System | 0 Adverse events |
| Age 18 - 49, Half Dose | Medical Events: Unsolicited Adverse Events | Special Senses | 2 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Respiratory System | 5 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Body as a Whole | 1 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Cardiovascular System | 0 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Digestive Sytem | 2 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Hematological and Lymphatic System | 1 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Musculoskeletal System | 1 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Skin and Appendages | 1 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Special Senses | 0 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Urogenital System | 0 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Symptions in Arm Given Shot | 0 Adverse events |
| Severe, Able to Work | Medical Events: Unsolicited Adverse Events | Headache | 1 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Hematological and Lymphatic System | 0 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Body as a Whole | 3 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Cardiovascular System | 0 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Headache | 1 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Symptions in Arm Given Shot | 0 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Digestive Sytem | 4 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Respiratory System | 3 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Special Senses | 1 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Urogenital System | 0 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Musculoskeletal System | 1 Adverse events |
| Severe, Lost Productivity | Medical Events: Unsolicited Adverse Events | Skin and Appendages | 0 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Body as a Whole | 1193 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Skin and Appendages | 1180 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Hematological and Lymphatic System | 1200 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Special Senses | 1198 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Digestive Sytem | 1182 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Headache | 1199 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Urogenital System | 1199 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Cardiovascular System | 1199 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Symptions in Arm Given Shot | 1189 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Respiratory System | 1167 Adverse events |
| No Events | Medical Events: Unsolicited Adverse Events | Musculoskeletal System | 1190 Adverse events |
Other Pre-specified
Race/Ethnicity Baseline Measure
Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures
Time frame: Enrollment Day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age 18 - 49, Full Dose | Race/Ethnicity Baseline Measure | African American | 54 Participants |
| Age 18 - 49, Full Dose | Race/Ethnicity Baseline Measure | Asian | 14 Participants |
| Age 18 - 49, Full Dose | Race/Ethnicity Baseline Measure | White | 454 Participants |
| Age 18 - 49, Full Dose | Race/Ethnicity Baseline Measure | Other/unknown | 10 Participants |
| Age 18 - 49, Full Dose | Race/Ethnicity Baseline Measure | Hispanic | 16 Participants |
| Age 18 - 49, Half Dose | Race/Ethnicity Baseline Measure | Other/unknown | 6 Participants |
| Age 18 - 49, Half Dose | Race/Ethnicity Baseline Measure | White | 491 Participants |
| Age 18 - 49, Half Dose | Race/Ethnicity Baseline Measure | African American | 46 Participants |
| Age 18 - 49, Half Dose | Race/Ethnicity Baseline Measure | Hispanic | 6 Participants |
| Age 18 - 49, Half Dose | Race/Ethnicity Baseline Measure | Asian | 7 Participants |