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Vaccine
Influenza Vaccine for Miscarriages (DE-FluVac Trial)
Phase 4
Waitlist Available
Led By David H Barad, MD, MS
Research Sponsored by Center for Human Reproduction
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 to 21 days (at time of egg retrieval)
Awards & highlights
DE-FluVac Trial Summary
This study is evaluating whether influenza vaccination can improve pregnancy rates in women undergoing in vitro fertilization.
Eligible Conditions
- Miscarriages
- Infertility
DE-FluVac Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 to 21 days (at time of egg retrieval)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 to 21 days (at time of egg retrieval)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Pregnancy
Secondary outcome measures
Evidence of immune activation
Implantation Rate
Side effects data
From 2015 Phase 4 trial • 985 Patients • NCT0229069164%
Tenderness
48%
Pain
35%
Redness
29%
Swelling
24%
Itching
20%
Muscle Ache
15%
Headache
12%
Fatigue
10%
Bruising
5%
Chills
4%
Nausea
1%
Vomiting
1%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Needle- Free
Needle and Syringe
DE-FluVac Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Influenza VaccineExperimental Treatment1 Intervention
O.5 mL single dose influenza vaccine suspension administered intramuscularly
Group II: Saline InjectionPlacebo Group1 Intervention
O.5 ml of sterile Saline administered intramuscularly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza B virus B/Brisbane/60/2008 antigen (propiolactone inactivated)
FDA approved
Find a Location
Who is running the clinical trial?
Center for Human ReproductionLead Sponsor
13 Previous Clinical Trials
1,041 Total Patients Enrolled
Foundation for Human ReproductionUNKNOWN
1 Previous Clinical Trials
238 Total Patients Enrolled
Norbert Gleicher, MDStudy DirectorMedical Director
8 Previous Clinical Trials
699 Total Patients Enrolled
Frequently Asked Questions
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