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Trial record 71 of 597 for:    Fluzone® | Studies With Results

Immune and Hormone Response to Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT01978262
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : October 11, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Biological: Seasonal Inactivated Influenza Vaccine
Enrollment 103

Recruitment Details 103 adult female subjects enrolled and 92 completed study over 3 vaccination seasons from 2013-2017. Each participant served as her own control and followed for 2 months: an Inactivated influenza vaccination (IIV) month and a observation/comparator month.
Pre-assignment Details Study specific screening occurred prior to enrollment. 180 screens completed
Arm/Group Title Healthy Women
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All women are to receive the quadrivalent influenza vaccine

Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Period Title: Overall Study
Started 103
Completed 92
Not Completed 11
Reason Not Completed
Withdrawal by Subject             9
Lost to Follow-up             2
Arm/Group Title Healthy Women
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All women are to receive the quadrivalent influenza vaccine

Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants
28
(19 to 39.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
92
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Hispanic or Latino
3
   3.3%
Not Hispanic or Latino
89
  96.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
American Indian or Alaska Native
1
   1.1%
Asian
11
  12.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
56
  60.9%
White
22
  23.9%
More than one race
1
   1.1%
Unknown or Not Reported
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants
92
1.Primary Outcome
Title Change in Levels of Progesterone After Influenza Vaccination
Hide Description To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation.
Time Frame 2 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Women (Vaccine) Healthy Women (Comparator)
Hide Arm/Group Description:

All women are to receive the quadrivalent influenza vaccine

Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

All women are to receive the quadrivalent influenza vaccine

Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Comparator Month

Overall Number of Participants Analyzed 92 92
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 0 0.62  (1.60) 0.43  (0.80)
Day 11 0.73  (1.40) 0.59  (0.92)
Day 17 4.59  (4.42) 4.53  (4.13)
Day 21 6.72  (4.59) 6.32  (3.70)
Day 28 0.55  (1.03) 0.92  (1.98)
2.Other Pre-specified Outcome
Title Cytokine Effect on Reproductive Hormone Levels
Hide Description To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.
Time Frame 2 months
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Cytokine Responses to Influenza Vaccine
Hide Description Identify optimal biomarkers of the inflammatory response after vaccination.
Time Frame 2 days
Outcome Measure Data Not Reported
Time Frame 7 days after vaccination, up to 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Women
Hide Arm/Group Description

All women are to receive the quadrivalent influenza vaccine

Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

All-Cause Mortality
Healthy Women
Affected / at Risk (%)
Total   0/92 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Women
Affected / at Risk (%) # Events
Total   0/92 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Women
Affected / at Risk (%) # Events
Total   73/92 (79.35%)    
Immune system disorders   
Chills  1  2/92 (2.17%)  2
Headache  1  23/92 (25.00%)  31
Malaise  1  11/92 (11.96%)  11
Musculoskeletal and connective tissue disorders   
Myalgia  1  10/92 (10.87%)  10
Skin and subcutaneous tissue disorders   
Ecchymosis * 1  2/92 (2.17%)  2
Eythema * 1  9/92 (9.78%)  9
Induration * 1  9/92 (9.78%)  9
Pain * 1  62/92 (67.39%)  72
Pruritis * 1  2/92 (2.17%)  2
Swelling * 1  9/92 (9.78%)  9
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Kawsar Talaat
Organization: Johns Hopkins University
Phone: 410-502-9627
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01978262     History of Changes
Other Study ID Numbers: CIR 292
200-2012-53664-002 ( Other Grant/Funding Number: CDC )
First Submitted: October 24, 2013
First Posted: November 7, 2013
Results First Submitted: August 8, 2018
Results First Posted: October 11, 2018
Last Update Posted: November 14, 2018