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The Influence of Chronic CMV Infection on Influenza Vaccine Responses (SLVP025)

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ClinicalTrials.gov Identifier: NCT02134184
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : December 26, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Cytomegalovirus Infections
Influenza
Intervention Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CMV Negative Group CMV Positive Group Recent CMV Converters
Hide Arm/Group Description

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the "recent" timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past

Period Title: Overall Study
Started 33 37 8
Completed 33 37 8
Not Completed 0 0 0
Arm/Group Title CMV Negative Group CMV Positive Group Recent CMV Converters Total
Hide Arm/Group Description

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

Total of all reporting groups
Overall Number of Baseline Participants 33 37 8 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 37 participants 8 participants 78 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  36.4%
16
  43.2%
1
  12.5%
29
  37.2%
>=65 years
21
  63.6%
21
  56.8%
7
  87.5%
49
  62.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 37 participants 8 participants 78 participants
66.96  (4.52) 67.46  (5.26) 66.75  (3.53) 67.21  (4.80)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 37 participants 8 participants 78 participants
Female
10
  30.3%
20
  54.1%
7
  87.5%
37
  47.4%
Male
23
  69.7%
17
  45.9%
1
  12.5%
41
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 37 participants 8 participants 78 participants
Hispanic or Latino
0
   0.0%
1
   2.7%
0
   0.0%
1
   1.3%
Not Hispanic or Latino
33
 100.0%
36
  97.3%
8
 100.0%
77
  98.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 37 participants 8 participants 78 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.0%
1
   2.7%
0
   0.0%
2
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
31
  93.9%
36
  97.3%
8
 100.0%
75
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.0%
0
   0.0%
0
   0.0%
1
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants 37 participants 8 participants 78 participants
33
 100.0%
37
 100.0%
8
 100.0%
78
 100.0%
1.Primary Outcome
Title Number of Participants From Each Arm Who Received Influenza Vaccine
Hide Description [Not Specified]
Time Frame Day 0 to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CMV Negative Group CMV Positive Group Recent CMV Converters
Hide Arm/Group Description:

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Overall Number of Participants Analyzed 33 37 8
Measure Type: Count of Participants
Unit of Measure: Participants
33
 100.0%
37
 100.0%
8
 100.0%
2.Secondary Outcome
Title Number of Participants With Related Adverse Events
Hide Description [Not Specified]
Time Frame Day 0 to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CMV Negative Group CMV Positive Group Recent CMV Converters
Hide Arm/Group Description:

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Overall Number of Participants Analyzed 33 37 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
3.Other Pre-specified Outcome
Title To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells
Hide Description [Not Specified]
Time Frame Day 0 to Day 28
Outcome Measure Data Not Reported
Time Frame Day 0 to Day 28 of study participation
Adverse Event Reporting Description Clinical Assessment performed at each visit
 
Arm/Group Title CMV Negative Group CMV Positive Group Recent CMV Converters
Hide Arm/Group Description

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

All-Cause Mortality
CMV Negative Group CMV Positive Group Recent CMV Converters
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CMV Negative Group CMV Positive Group Recent CMV Converters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/37 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CMV Negative Group CMV Positive Group Recent CMV Converters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/37 (0.00%)      0/8 (0.00%)    
Respiratory, thoracic and mediastinal disorders       
Pneumonia  [1]  1/33 (3.03%)  1 0/37 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Community Acquired Pneumonia
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr Cornelia Dekker
Organization: Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT02134184     History of Changes
Other Study ID Numbers: SU-25199
1U19AI090019-01 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: December 16, 2016
Results First Posted: December 26, 2016
Last Update Posted: February 23, 2017