Trial Outcomes & Findings for Immune and Hormone Response to Influenza Vaccine (NCT NCT01978262)
NCT ID: NCT01978262
Last Updated: 2018-12-27
Results Overview
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.
COMPLETED
PHASE4
103 participants
2 months
2018-12-27
Participant Flow
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.
Study specific screening occurred prior to enrollment. 180 screens completed
Participant milestones
| Measure |
Healthy Women
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Healthy Women
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Immune and Hormone Response to Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Healthy Women
n=92 Participants
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
|
|---|---|
|
Age, Continuous
|
28 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 monthsTo 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.
Outcome measures
| Measure |
Healthy Women (Vaccine)
n=92 Participants
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
|
Healthy Women (Comparator)
n=92 Participants
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Comparator Month
|
|---|---|---|
|
Change in Levels of Progesterone After Influenza Vaccination
Progesterone Day 11
|
0.73 ng/ml
Standard Deviation 1.40
|
0.59 ng/ml
Standard Deviation 0.92
|
|
Change in Levels of Progesterone After Influenza Vaccination
Progesterone Day 0
|
0.62 ng/ml
Standard Deviation 1.60
|
0.43 ng/ml
Standard Deviation 0.80
|
|
Change in Levels of Progesterone After Influenza Vaccination
Progesterone Day 17
|
4.59 ng/ml
Standard Deviation 4.42
|
4.53 ng/ml
Standard Deviation 4.13
|
|
Change in Levels of Progesterone After Influenza Vaccination
Progesterone Day 21
|
6.72 ng/ml
Standard Deviation 4.59
|
6.32 ng/ml
Standard Deviation 3.70
|
|
Change in Levels of Progesterone After Influenza Vaccination
Progesterone Day 28
|
0.55 ng/ml
Standard Deviation 1.03
|
0.92 ng/ml
Standard Deviation 1.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthsTo explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysIdentify optimal biomarkers of the inflammatory response after vaccination.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Women
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Women
n=92 participants at risk
All women are to receive the quadrivalent influenza vaccine
Seasonal Inactivated Influenza Vaccine: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
|
|---|---|
|
Immune system disorders
Chills
|
2.2%
2/92 • Number of events 2 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.2%
2/92 • Number of events 2 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Eythema
|
9.8%
9/92 • Number of events 9 • 7 days after vaccination, up to 2 months
|
|
Immune system disorders
Headache
|
25.0%
23/92 • Number of events 31 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Induration
|
9.8%
9/92 • Number of events 9 • 7 days after vaccination, up to 2 months
|
|
Immune system disorders
Malaise
|
12.0%
11/92 • Number of events 11 • 7 days after vaccination, up to 2 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
10/92 • Number of events 10 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Pain
|
67.4%
62/92 • Number of events 72 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.2%
2/92 • Number of events 2 • 7 days after vaccination, up to 2 months
|
|
Skin and subcutaneous tissue disorders
Swelling
|
9.8%
9/92 • Number of events 9 • 7 days after vaccination, up to 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place