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NCT01978262 · ClinicalTrials.gov registry record · Phase 4
Immune and Hormone Response to Influenza Vaccine
A Phase 4 study of Healthy, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
- 1
- Study location
NCT01978262: Completed Phase 4 study of Healthy, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT01978262 is a Phase 4 study of Healthy that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 103 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01978262, a Phase 4 study of Healthy, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this pilot research project is to look at the effect of the inactivated influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response known as cytokines or signal molecules. The investigators also want to see if the timing of vaccine administration has any effect on women's reproductive hormones. The investigators hypothesis is that influenza vaccine given right before ovulation may change the hormone levels usually seen after ovulation. Thi
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Seasonal Inactivated Influenza Vaccine
Study Locations (1)
Maryland
- Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-08 |
| Phase | Phase 4 |
What the finished NCT01978262 record still lists
NCT01978262 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Seasonal Inactivated Influenza Vaccine is the first listed.
NCT01978262 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01978262 about?
NCT01978262 is a clinical study titled "Immune and Hormone Response to Influenza Vaccine". The purpose of this pilot research project is to look at the effect of the inactivated influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response known as cytokines or signal molecules. The investigators also want to see if the timing of vaccine administration has any e...
What is the current status of trial NCT01978262?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2013-10. Estimated completion is 2017-08.
What conditions does trial NCT01978262 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01978262?
The interventions under investigation include: Seasonal Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01978262?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01978262 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01978262's enrollment target sits among peer trials
103 215th of 1090 higher than 875 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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