Trial Outcomes & Findings for Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients (NCT NCT01215734)
NCT ID: NCT01215734
Last Updated: 2013-03-08
Results Overview
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever \>= 100.4 degrees Fahrenheit, or change in activity level.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Day of TIV to 7 days after TIV
Results posted on
2013-03-08
Participant Flow
This phase X, double-blind study was conducted from September 2011 - April 2012.
Forty-seven patients consented to participate in this study, three were determined ineligible.
Participant milestones
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
15
|
|
Overall Study
COMPLETED
|
29
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
Baseline characteristics by cohort
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
n=29 Participants
Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
n=15 Participants
Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49 years
STANDARD_DEVIATION 14 • n=7 Participants
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
15 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of TIV to 7 days after TIVPopulation: Patients who received either the high-dose TIV or the standard dose TIV
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever \>= 100.4 degrees Fahrenheit, or change in activity level.
Outcome measures
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
n=29 Participants
High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms \[µg\] per antigen) on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
n=15 Participants
Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
|
|---|---|---|
|
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Local Adverse Events
|
18 participants
|
4 participants
|
|
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Systemic Adverse Events
|
14 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Before TIV and 28-42 days after TIVPopulation: Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.
Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus
Outcome measures
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
n=24 Participants
High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms \[µg\] per antigen) on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
n=14 Participants
Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
|
|---|---|---|
|
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
H1N1 Influenza
|
12 participants
|
5 participants
|
|
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
H3N2 Influenza
|
10 participants
|
5 participants
|
|
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
B Influenza
|
10 participants
|
6 participants
|
Adverse Events
High-Dose Trivalent Inactivated Influenza Vaccine
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Dose Trivalent Inactivated Flu Vaccine
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
n=29 participants at risk
Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
n=15 participants at risk
Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
|
|---|---|---|
|
General disorders
fever
|
3.4%
1/29 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
chest pain, cardiac
|
0.00%
0/29
|
6.7%
1/15 • Number of events 2
|
|
Cardiac disorders
heart failure
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
palpitations
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
pericardial effusion
|
3.4%
1/29 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
abdominal pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
diarrhea
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
nausea
|
6.9%
2/29 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
vomiting
|
3.4%
1/29 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
malaise
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Hepatobiliary disorders
Cholecystitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Infections and infestations other
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
3.4%
1/29 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Investigations
weight loss
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Planned knee replacement surgery
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyneuropathy
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Presyncope
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Transient ischemic attacks
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Renal and urinary disorders
Acute kidney injury
|
6.9%
2/29 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.4%
1/29 • Number of events 1
|
13.3%
2/15 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
bonchitis obliterans
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Methicillin-resistant Staphylococcus aureus bacteremia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
rectal abscess
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
diffuse muscle pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
High-Dose Trivalent Inactivated Influenza Vaccine
n=29 participants at risk
Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1
|
Standard Dose Trivalent Inactivated Flu Vaccine
n=15 participants at risk
Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
10.3%
3/29 • Number of events 3
|
6.7%
1/15 • Number of events 1
|
|
Investigations
investigations, other
|
6.9%
2/29 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
anorexia
|
6.9%
2/29 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.4%
1/29 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
General disorders
edema limbs
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
hepatobiliary disorders, other
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
mucositits oral
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin and other subcutaneous disorders-other
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/29
|
6.7%
1/15 • Number of events 1
|
Additional Information
Natasha Halasa, Associate Professor of Pediatrics
Vanderbilt University
Phone: 615-322-3346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place