Trial Outcomes & Findings for Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy (NCT NCT01666782)
NCT ID: NCT01666782
Last Updated: 2016-06-24
Results Overview
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline and 28 days
Results posted on
2016-06-24
Participant Flow
105 patients were enrolled but only 100 had evaluable data. 4 patients received a vaccination both in years 1 and 2 of the study- only year 1 results were included in the analysis. 1 additional patient was excluded from the efficacy analysis when it was revealed he had received a second vaccination in the same season.
Participant milestones
| Measure |
High-Dose Influenza Vaccine
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
51
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
High-Dose Influenza Vaccine
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
Overall Study
Received 2 doses of vaccine
|
0
|
1
|
|
Overall Study
Enrolled both years; year 1 data used
|
4
|
0
|
Baseline Characteristics
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.94 years
STANDARD_DEVIATION 7.16 • n=99 Participants
|
52.9 years
STANDARD_DEVIATION 7.95 • n=107 Participants
|
53.4 years
STANDARD_DEVIATION 7.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysMeasure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Post Vaccination H3N2 Antigen
|
1143.4 titers
Interval 739.6 to 1547.3
|
811.2 titers
Interval 401.2 to 1221.3
|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Pre Vaccination H3N2 Antigen
|
134.1 titers
Interval 54.9 to 213.2
|
143.2 titers
Interval 64.5 to 221.9
|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Pre Vaccination B Antigen
|
31.4 titers
Interval 20.4 to 42.3
|
54.7 titers
Interval 31.6 to 77.8
|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Post Vaccination H1N1 Antigen
|
1350.1 titers
Interval 819.8 to 1880.4
|
979.1 titers
Interval 609.1 to 1349.0
|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Post Vaccination B Antigen
|
351.6 titers
Interval 215.6 to 487.7
|
228 titers
Interval 129.9 to 326.2
|
|
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Pre Vaccination H1N1 Antigen
|
125.2 titers
Interval 74.6 to 175.8
|
266.1 titers
Interval 52.1 to 480.1
|
SECONDARY outcome
Timeframe: 28 daysSeroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
H1N1 Antigen
|
96 percentage of participants
|
90 percentage of participants
|
|
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
H3N2 Antigen
|
96 percentage of participants
|
96 percentage of participants
|
|
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
B Antigen
|
88 percentage of participants
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 28 daysSeroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
H1N1 Antigen
|
72 percentage of participants
|
46 percentage of participants
|
|
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
H3N2 Antigen
|
80 percentage of participants
|
58 percentage of participants
|
|
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
B Antigen
|
80 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 7 daysLocal solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site itching-moderate
|
0 participants
|
0 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site pain- mild
|
13 participants
|
10 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site pain-moderate
|
3 participants
|
1 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site swelling-mild
|
4 participants
|
2 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site swelling-moderate
|
1 participants
|
0 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site redness-mild
|
2 participants
|
2 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site redness-moderate
|
1 participants
|
0 participants
|
|
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Injection site itching-mild
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysSystemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Fever-mild
|
2 participants
|
1 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Fever-moderate
|
1 participants
|
1 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Fever-severe
|
0 participants
|
0 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Headache-mild
|
9 participants
|
12 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Headache-moderate
|
6 participants
|
4 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Headache-severe
|
1 participants
|
0 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Malaise-mild
|
10 participants
|
13 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Malaise-moderate
|
10 participants
|
6 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Malaise-severe
|
6 participants
|
3 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Myalgia-mild
|
12 participants
|
12 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Myalgia-moderate
|
8 participants
|
3 participants
|
|
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Myalgia-severe
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 28 daysUnsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
Outcome measures
| Measure |
High-Dose Influenza Vaccine
n=50 Participants
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 Participants
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Fatigue: Grade 1 or 2
|
6 participants
|
4 participants
|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Fatigue: Grade 3
|
1 participants
|
0 participants
|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Nausea: Grade 1 or 2
|
3 participants
|
11 participants
|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Nausea: Grade 3
|
1 participants
|
0 participants
|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Vomiting: Grade 1 or 2
|
2 participants
|
3 participants
|
|
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Vomiting: Grade 3
|
1 participants
|
0 participants
|
Adverse Events
High-Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Standard Trivalent Influenza Vaccine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High-Dose Influenza Vaccine
n=50 participants at risk
High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
|
Standard Trivalent Influenza Vaccine
n=50 participants at risk
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
|
|---|---|---|
|
General disorders
Malaise
|
52.0%
26/50 • Number of events 26 • 28 +/- 7 days post-vaccination
|
44.0%
22/50 • Number of events 22 • 28 +/- 7 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.0%
22/50 • Number of events 22 • 28 +/- 7 days post-vaccination
|
32.0%
16/50 • Number of events 16 • 28 +/- 7 days post-vaccination
|
|
Nervous system disorders
Headache
|
32.0%
16/50 • Number of events 16 • 28 +/- 7 days post-vaccination
|
32.0%
16/50 • Number of events 16 • 28 +/- 7 days post-vaccination
|
|
General disorders
Injection-site pain
|
32.0%
16/50 • Number of events 16 • 28 +/- 7 days post-vaccination
|
22.0%
11/50 • Number of events 11 • 28 +/- 7 days post-vaccination
|
|
General disorders
Injection-site swelling
|
10.0%
5/50 • Number of events 5 • 28 +/- 7 days post-vaccination
|
4.0%
2/50 • Number of events 2 • 28 +/- 7 days post-vaccination
|
|
General disorders
Injection-site itching
|
8.0%
4/50 • Number of events 4 • 28 +/- 7 days post-vaccination
|
0.00%
0/50 • 28 +/- 7 days post-vaccination
|
|
General disorders
Fever
|
6.0%
3/50 • Number of events 3 • 28 +/- 7 days post-vaccination
|
4.0%
2/50 • Number of events 2 • 28 +/- 7 days post-vaccination
|
|
General disorders
Injection-site redness
|
6.0%
3/50 • Number of events 3 • 28 +/- 7 days post-vaccination
|
4.0%
2/50 • Number of events 2 • 28 +/- 7 days post-vaccination
|
|
General disorders
Fatigue
|
14.0%
7/50 • Number of events 7 • 28 +/- 7 days post-vaccination
|
8.0%
4/50 • Number of events 4 • 28 +/- 7 days post-vaccination
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50 • Number of events 4 • 28 +/- 7 days post-vaccination
|
22.0%
11/50 • Number of events 11 • 28 +/- 7 days post-vaccination
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 3 • 28 +/- 7 days post-vaccination
|
6.0%
3/50 • Number of events 3 • 28 +/- 7 days post-vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All research data and results generated during the course of or as a result of the Research Project shall be the property of Investigator and/or institution. Sanofi Pasteur will have access to the full set of data collected during the Research Project. The text of any manuscript, abstract or oral presentation based on this Research Project will be provided to Sanofi Pasteur at least 30 days prior to submission to a journal, a congress, or prior to an oral presentation.
- Publication restrictions are in place
Restriction type: OTHER