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CompletedNCT01666782IMMUNEUpdated Jun 24, 2016Results posted

Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

A Phase 2 interventional study of Standard Trivalent Influenza Vaccine and High-Dose Influenza Vaccine in Cancer and Influenza Viral Infections, sponsored by Saad Jamshed MD. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by Saad Jamshed MD · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

02

Conditions studied

  • Cancer
  • Influenza Viral Infections

Keywords

  • Influenza vaccine
  • Oncology
  • Chemotherapy
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 105 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

This is the only study on the registry with Saad Jamshed MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 years old to less than 65 years old
  2. Subjects with malignancy must be receiving chemotherapy
  3. Medically stable
  4. Able to understand and willingness to sign a written informed consent
  5. Able to comply with study procedures
  6. Life expectancy of more than 3 months

  7. Adequate organ function:

    • ANC >1000/mm3
    • Platelet >100,000/uL
    • Creatinine \<2 mg/dL
    • AST and ALT \<3 times the ULN

Exclusion criteria

Exclusion Criteria:

  1. Allergy to eggs
  2. Prior allergy to Influenza Vaccine
  3. History of Guillain-Barre Syndrome
  4. Current febrile illness
  5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
  6. Autologous or Allogenic Stem Cell Transplant with in a year
  7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    High-Dose Influenza Vaccine

    Biological: High-Dose Influenza Vaccine

  • Active comparator
    Standard Trivalent Influenza Vaccine

    Biological: Standard Trivalent Influenza Vaccine

Interventions

  • BiologicalStandard 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.

    Also known as: Fluzone

  • BiologicalHigh-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.

    Also known as: Fluzone High-Dose

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: Baseline and 28 days

Secondary outcomes

  1. The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

    Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.

    Time frame: 28 days

  2. The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

    Seroconversion 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.

    Time frame: Baseline and 28 days

  3. Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.

    Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

    Time frame: 7 days

  4. Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.

    Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

    Time frame: 7 days

  5. Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.

    Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

    Time frame: 28 days

07

Results

Posted May 24, 2016

Participant flow

Participant flow — Overall Study
MilestoneHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
Started5451
Completed5050
Not completed41
Withdrew: Received 2 doses of vaccine01
Withdrew: Enrolled both years; year 1 data used40

Outcome measures

PrimaryThe 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.

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.

Time frame:
Baseline and 28 days
Reported as:
Geometric mean · titers
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.
titersHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
Pre Vaccination H1N1 Antigen125.2 (74.6 to 175.8)266.1 (52.1 to 480.1)
Pre Vaccination H3N2 Antigen134.1 (54.9 to 213.2)143.2 (64.5 to 221.9)
Pre Vaccination B Antigen31.4 (20.4 to 42.3)54.7 (31.6 to 77.8)
Post Vaccination H1N1 Antigen1350.1 (819.8 to 1880.4)979.1 (609.1 to 1349.0)
Post Vaccination H3N2 Antigen1143.4 (739.6 to 1547.3)811.2 (401.2 to 1221.3)
Post Vaccination B Antigen351.6 (215.6 to 487.7)228 (129.9 to 326.2)
SecondaryThe Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.

Time frame:
28 days
Reported as:
Number · 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.
percentage of participantsHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
H1N1 Antigen9690
H3N2 Antigen9696
B Antigen8872
SecondaryThe Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

Seroconversion 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.

Time frame:
Baseline and 28 days
Reported as:
Number · 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.
percentage of participantsHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
H1N1 Antigen7246
H3N2 Antigen8058
B Antigen8044
SecondaryEvaluate and Compare the Local Solicited Adverse Events to Both Vaccines.

Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Time frame:
7 days
Reported as:
Number · participants
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
participantsHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
Injection site pain- mild1310
Injection site pain-moderate31
Injection site swelling-mild42
Injection site swelling-moderate10
Injection site redness-mild22
Injection site redness-moderate10
Injection site itching-mild40
Injection site itching-moderate00
SecondaryEvaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.

Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Time frame:
7 days
Reported as:
Number · participants
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
participantsHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
Fever-mild21
Fever-moderate11
Fever-severe00
Headache-mild912
Headache-moderate64
Headache-severe10
Malaise-mild1013
Malaise-moderate106
Malaise-severe63
Myalgia-mild1212
Myalgia-moderate83
Myalgia-severe21
SecondaryEvaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.

Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

Time frame:
28 days
Reported as:
Number · participants
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
participantsHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
Fatigue: Grade 1 or 264
Fatigue: Grade 310
Nausea: Grade 1 or 2311
Nausea: Grade 310
Vomiting: Grade 1 or 223
Vomiting: Grade 310

Adverse events

Collected over 28 +/- 7 days post-vaccination. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High-Dose Influenza Vaccine—0/50 (0%)26/50 (52%)
Standard Trivalent Influenza Vaccine—0/50 (0%)22/50 (44%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventHigh-Dose Influenza VaccineStandard Trivalent Influenza Vaccine
MalaiseGeneral disorders26/5022/50
MyalgiaMusculoskeletal and connective tissue disorders22/5016/50
HeadacheNervous system disorders16/5016/50
Injection-site painGeneral disorders16/5011/50
NauseaGastrointestinal disorders4/5011/50
FatigueGeneral disorders7/504/50
Injection-site swellingGeneral disorders5/502/50
Injection-site itchingGeneral disorders4/500/50
FeverGeneral disorders3/502/50
Injection-site rednessGeneral disorders3/502/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)High-Dose Influenza VaccineStandard Trivalent Influenza VaccineTotal
Mean53.94 ± 7.1652.9 ± 7.9553.4 ± 7.54
Sex: Female, Male
Sex: Female, Male(Participants)High-Dose Influenza VaccineStandard Trivalent Influenza VaccineTotal
Female312657
Male192443
Region of Enrollment
Region of Enrollment(participants)High-Dose Influenza VaccineStandard Trivalent Influenza VaccineTotal
United States5050100
08

Study locations

2 sites
  • Rochester General Hospital
    Rochester, New York 14621, United States
  • Lipson Cancer Center Linden Oaks Medical Campus
    Rochester, New York 14625, United States
09

References and documents

Publications

  • Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22. PubMed 26721330 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01666782
Lead sponsor
Saad Jamshed MD
Collaborators
Sanofi
Responsible party
Saad Jamshed MD (Principal Investigator, Rochester General Hospital) — Sponsor-investigator
First posted
Aug 16, 2012
Start date
Aug 2012
Primary completion
Jun 2015
Completion
Dec 2015
Results posted
May 24, 2016
Last update
Jun 24, 2016

Study contacts

Saad Jamshed, MD
principal investigator · Rochester General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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