Trial Outcomes & Findings for Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine (NCT NCT00283283)

Last Updated: 2021-02-12

Results Overview

Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1316 participants

Primary outcome timeframe

21 days post-vaccincation

Results posted on

2021-02-12

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Full Dose, Age 18-49 Subjects age 18-49 receiving full dose	Half Dose, Age 18-49 Subjects age 18-49 receiving half dose	Full Dose, Age 50-64 Subjects age 50-64 receiving full dose	Half Dose, Age 50-64 Subjects age 50-64 receiving half dose
Overall Study STARTED	274	284	280	276
Overall Study COMPLETED	274	284	280	276
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Half Dose, Age 50-64 n=276 Participants Previously Vaccinated Subjects Receiving Half Dose Aged 50-64 Years	Total n=1114 Participants Total of all reporting groups	Half Dose, Age 18-49 n=284 Participants Previously Vaccinated Subjects Receiving Half Dose Aged 18-49 Years	Full Dose, Age 50-64 n=280 Participants Previously Vaccinated Subjects Receiving Full Dose Aged 50-64 Years	Full Dose, Age 18-49 n=274 Participants Previously Vaccinated Subjects Receiving Full Dose Aged 18-49 Years
Age, Customized	276 years n=4 Participants	1114 years n=21 Participants	284 years n=7 Participants	280 years n=5 Participants	274 years n=5 Participants
Sex: Female, Male Female	118 Participants n=4 Participants	484 Participants n=21 Participants	121 Participants n=7 Participants	119 Participants n=5 Participants	126 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=4 Participants	630 Participants n=21 Participants	163 Participants n=7 Participants	161 Participants n=5 Participants	148 Participants n=5 Participants
Region of Enrollment United States	276 participants n=4 Participants	1114 participants n=21 Participants	284 participants n=7 Participants	280 participants n=5 Participants	274 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49

Outcome measures

Outcome measures
Measure	Age 18 - 49, Full Dose n=274 Participants 0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Age 18 - 49, Half Dose n=284 Participants 0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Severe, Able to Work Severe but able to work	Severe, Lost Productivity Severe and lost productivity	No Events No adverse events recorded
Immune Response: Age 18-49 H1N1 - GMT	28.8 Anti-body response (GMT) Interval 25.2 to 32.8	21.3 Anti-body response (GMT) Interval 18.9 to 24.0	—	—	—
Immune Response: Age 18-49 H3N2 - GMT	55.2 Anti-body response (GMT) Interval 48.7 to 62.5	45.0 Anti-body response (GMT) Interval 39.7 to 50.9	—	—	—
Immune Response: Age 18-49 B - GMT	69.6 Anti-body response (GMT) Interval 61.4 to 78.9	54.8 Anti-body response (GMT) Interval 49.1 to 61.2	—	—	—

PRIMARY outcome

Timeframe: 21 days post-vaccincation

Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64

Outcome measures

Outcome measures
Measure	Age 18 - 49, Full Dose n=280 Participants 0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Age 18 - 49, Half Dose n=276 Participants 0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Severe, Able to Work Severe but able to work	Severe, Lost Productivity Severe and lost productivity	No Events No adverse events recorded
Immune Response: Age 50-64 H1N1 - GMT	21.4 Anti-body response (GMT) Interval 18.6 to 24.7	14.2 Anti-body response (GMT) Interval 12.7 to 15.9	—	—	—
Immune Response: Age 50-64 H3N2 - GMT	59.0 Anti-body response (GMT) Interval 51.4 to 67.8	39.1 Anti-body response (GMT) Interval 34.3 to 44.6	—	—	—
Immune Response: Age 50-64 B - GMT	52.1 Anti-body response (GMT) Interval 45.5 to 59.8	36.8 Anti-body response (GMT) Interval 32.4 to 41.9	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Age 18 - 49, Full Dose n=1203 Participants 0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Age 18 - 49, Half Dose n=1203 Participants 0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Severe, Able to Work n=1203 Participants Severe but able to work	Severe, Lost Productivity n=1203 Participants Severe and lost productivity	No Events n=1203 Participants No adverse events recorded
Medical Events: Unsolicited Adverse Events Body as a Whole	0 Adverse events	6 Adverse events	1 Adverse events	3 Adverse events	1193 Adverse events
Medical Events: Unsolicited Adverse Events Cardiovascular System	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	1199 Adverse events
Medical Events: Unsolicited Adverse Events Digestive Sytem	12 Adverse events	3 Adverse events	2 Adverse events	4 Adverse events	1182 Adverse events
Medical Events: Unsolicited Adverse Events Hematological and Lymphatic System	2 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1200 Adverse events
Medical Events: Unsolicited Adverse Events Musculoskeletal System	6 Adverse events	5 Adverse events	1 Adverse events	1 Adverse events	1190 Adverse events
Medical Events: Unsolicited Adverse Events Respiratory System	10 Adverse events	18 Adverse events	5 Adverse events	3 Adverse events	1167 Adverse events
Medical Events: Unsolicited Adverse Events Skin and Appendages	14 Adverse events	8 Adverse events	1 Adverse events	0 Adverse events	1180 Adverse events
Medical Events: Unsolicited Adverse Events Special Senses	2 Adverse events	2 Adverse events	0 Adverse events	1 Adverse events	1198 Adverse events
Medical Events: Unsolicited Adverse Events Urogenital System	0 Adverse events	4 Adverse events	0 Adverse events	0 Adverse events	1199 Adverse events
Medical Events: Unsolicited Adverse Events Symptions in Arm Given Shot	13 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1189 Adverse events
Medical Events: Unsolicited Adverse Events Headache	0 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	1199 Adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment Day

Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures

Outcome measures

Outcome measures
Measure	Age 18 - 49, Full Dose n=558 Participants 0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Age 18 - 49, Half Dose n=556 Participants 0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Severe, Able to Work Severe but able to work	Severe, Lost Productivity Severe and lost productivity	No Events No adverse events recorded
Race/Ethnicity Baseline Measure White	454 Participants	491 Participants	—	—	—
Race/Ethnicity Baseline Measure African American	54 Participants	46 Participants	—	—	—
Race/Ethnicity Baseline Measure Hispanic	16 Participants	6 Participants	—	—	—
Race/Ethnicity Baseline Measure Asian	14 Participants	7 Participants	—	—	—
Race/Ethnicity Baseline Measure Other/unknown	10 Participants	6 Participants	—	—	—

Adverse Events

Full Dose

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Half Dose

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Full Dose n=554 participants at risk 0.5ml, 15µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinin antigen per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002	Half Dose n=556 participants at risk 0.25ml, 7.5µg Fluzone® (Aventis Pasteur inactivated influenza vaccine) hemagglutinia per strain Fluzone® (Aventis Pasteur inactivated influenza vaccine): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Cardiac disorders Carotid endarterectomey	0.00% 0/554 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal	0.18% 1/556 • Number of events 1 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal
Surgical and medical procedures Melanoma exised	0.18% 1/554 • Number of events 1 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal	0.00% 0/556 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.18% 1/554 • Number of events 1 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal	0.00% 0/556 • 3 - 6 months following vaccination Of the original study population, 1203 previously vaccinated subjects completed the 3-day post vaccination side effects diary and have been included in this analysis. AEs were collected with diary cards, health surveys, and VAERS forms and listed by subject Grading of AE's: 1 = Mild; 2 = Moderate; 3 = Severe, able to work; 4 = Severe, lost productivity; 5 = Life-threatening; 6 = Fatal

Other adverse events

Additional Information

COL Renata J. M. Engler, MD

Walter Reed National Vaccine Healthcare Center Network

Phone: 202-782-9461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place