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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Saad Jamshed MD, Rochester General Hospital
ClinicalTrials.gov Identifier:
NCT01666782
First received: August 14, 2012
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Prevention
Conditions: Cancer
Influenza Viral Infections
Interventions: Biological: Standard Trivalent Influenza Vaccine
Biological: High-Dose Influenza Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    High-Dose Influenza Vaccine     Standard Trivalent Influenza Vaccine  
STARTED     54     51  
COMPLETED     50     50  
NOT COMPLETED     4     1  
Received 2 doses of vaccine                 0                 1  
Enrolled both years; year 1 data used                 4                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    High-Dose Influenza Vaccine     Standard Trivalent Influenza Vaccine     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: years]
Mean (Standard Deviation)
  53.94  (7.16)     52.9  (7.95)     53.4  (7.54)  
Gender  
[units: participants]
     
Female     31     26     57  
Male     19     24     43  
Region of Enrollment  
[units: participants]
     
United States     50     50     100  



  Outcome Measures
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1.  Primary:   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.   [ Time Frame: Baseline and 28 days ]

2.  Secondary:   The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.   [ Time Frame: 28 days ]

3.  Secondary:   The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.   [ Time Frame: Baseline and 28 days ]

4.  Secondary:   Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.   [ Time Frame: 7 days ]

5.  Secondary:   Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.   [ Time Frame: 7 days ]

6.  Secondary:   Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Saad Jamshed, MD
Organization: Rochester General Hospital
phone: 585-922-4020
e-mail: Saad.Jamshed@rochesterregional.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Saad Jamshed MD, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT01666782     History of Changes
Other Study ID Numbers: CIC 1336-B12-1
Study First Received: August 14, 2012
Results First Received: January 29, 2016
Last Updated: May 23, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board