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Virus Vaccine

LAIV vs IIV for Flu Protection in Twins (FLU-TW Trial)

Phase 1
Waitlist Available
Led By Philip M Grant
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Availability for follow-up for the planned duration of the study
2-20 year old male and female patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 28
Awards & highlights

FLU-TW Trial Summary

This trial is testing whether LAIV or IIV is better at protecting against the flu in identical and fraternal twins.

Who is the study for?
This trial is for male and female twins aged 2-20 who can consent to the study, with their twin also participating. They must be healthy without immune impairments, severe allergies to vaccine components like egg or gelatin, recent use of immunosuppressants, or a history of severe reactions to flu vaccines.Check my eligibility
What is being tested?
The study compares immune responses in twins given two different types of flu vaccines: one group receives a live attenuated influenza vaccine (LAIV4) and the other an inactivated influenza vaccine (IIV4). The goal is to see which produces a better immune response.See study design
What are the potential side effects?
Possible side effects include mild symptoms like soreness at the injection site, headache, fever, muscle pain. LAIV4 may cause nasal congestion or runny nose. Severe allergic reactions are rare but possible.

FLU-TW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

FLU-TW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HAI titers

FLU-TW Trial Design

2Treatment groups
Experimental Treatment
Group I: MZ twins (IIV or LAIV4)Experimental Treatment2 Interventions
Up to 20 healthy monozygotic (MZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Group II: DZ twins (IIV or LAIV4)Experimental Treatment2 Interventions
Up to 20 healthy monozygotic (MZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Live attenuated influenza vaccine (LAIV4)
2019
Completed Phase 1
~20
Inactivated Influenza Vaccine (IIV4)
2019
Completed Phase 3
~1370

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,373 Previous Clinical Trials
17,327,944 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,678 Previous Clinical Trials
6,909,778 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,483,084 Total Patients Enrolled

Media Library

Inactivated Influenza Vaccine (IIV4) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03898986 — Phase 1
Influenza Research Study Groups: MZ twins (IIV or LAIV4), DZ twins (IIV or LAIV4)
Influenza Clinical Trial 2023: Inactivated Influenza Vaccine (IIV4) Highlights & Side Effects. Trial Name: NCT03898986 — Phase 1
Inactivated Influenza Vaccine (IIV4) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03898986 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the LAIV4 influenza vaccine have any short or long-term risks?

"Live attenuated influenza vaccine (LAIV4) is a treatment that has been approved, so it received a score of 3."

Answered by AI

Are there other examples of medical research using Live attenuated influenza vaccine (LAIV4)?

"Currently, there are 22 clinical trials underway for Live attenuated influenza vaccine (LAIV4), with 1 trial in Phase 3. While some of the studies are based in Stanford, California, there are 28 locations across the United States conducting trials for Live attenuated influenza vaccine (LAIV4)."

Answered by AI

Because this research is cutting-edge, are investigators only screening participants who fall within a certain age range?

"Children aged 2 to 20 years old are the only patients that fit the requirements for this particular trial. However, there are 22 other clinical trials that might be more applicable for patients under 18 or over 65."

Answered by AI
~3 spots leftby Mar 2025