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Vaccine

H2N3 Influenza Vaccine for Flu

Phase 1
Recruiting
Research Sponsored by Seqirus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 8, day 22, day 29, day 43
Awards & highlights

Study Summary

This trial evaluates 6 different versions of a flu vaccine in 600 healthy adults over 12 months, assessing safety and effectiveness.

Who is the study for?
Adults who can follow the study plan, use effective birth control if of childbearing potential, and are not born in 1968. Excluded are pregnant or breastfeeding women, those with immune system issues, recent recipients of certain medications or vaccines (excluding COVID-19 vaccines), individuals with a BMI ≥35 kg/m2, or known allergies to vaccine components.Check my eligibility
What is being tested?
The trial is testing six variations of H2N3 influenza vaccines with different doses and adjuvant combinations on healthy adults. Participants will receive two injections: one on Day 1 and another on Day 22, followed by a year-long observation period for immune response and safety.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site (like pain or swelling), flu-like symptoms such as fever and fatigue within ten days post-vaccination. Other adverse events may be reported up to three weeks after each shot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 8, day 22, day 29, day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 8, day 22, day 29, day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMFI of HI antibodies against homologous H2N3 strain - Day 22
GMFI of HI antibodies against homologous H2N3 strain - Day 29
GMFI of HI antibodies against homologous H2N3 strain - Day 43
+37 more
Secondary outcome measures
GMFI of ELLA titer as a measure of anti-NA immunogenicity- Persistence
GMFI of ELLA titers as a measure of anti-NA immunogenicity
GMFI of HI antibodies against homologous H2N3 strain - Persistence
+11 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group FExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + high dose MF59 adjuvant
Group II: Group EExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of lowest dose A/H2N3c + high dose MF59 adjuvant
Group III: Group DExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c non-adjuvanted
Group IV: Group CExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c + standard dose MF59 adjuvant
Group V: Group BExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of intermediate dose A/H2N3c + standard dose MF59 adjuvant
Group VI: Group AExperimental Treatment1 Intervention
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + standard dose MF59 adjuvant

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,349 Total Patients Enrolled
SeqirusLead Sponsor
59 Previous Clinical Trials
1,080,470 Total Patients Enrolled
Clinical Science & StrategyStudy ChairSeqirus

Media Library

Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05875961 — Phase 1
Viral Infections Research Study Groups: Group A, Group B, Group C, Group D, Group E, Group F
Viral Infections Clinical Trial 2023: Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines Highlights & Side Effects. Trial Name: NCT05875961 — Phase 1
Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05875961 — Phase 1

Frequently Asked Questions

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

What are the hoped-for results of this investigation?

"Seqirus, the study sponsor, has identified GMT of HI antibodies against homologous H2N3 strain - Day 8 as the primary outcome to be monitored over a single day. Secondary outcomes that will also be tracked include GMFI of ELLA titers for anti-NA immunogenicity, Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity and GMT of HI antibodies against homologous H2N3 strain - Persistence which is defined at 6 and 12 months postvaccination 2."

Answered by AI

What risk factors are associated with Group A to the general population?

"Given its status as a Phase 1 trial, where there is restricted data for efficacy and safety, Group A received a score of 1 on our team at Power's rating scale."

Answered by AI

In how many locations are participants able to access this clinical trial?

"The trial is running in a variety of places, such as De La Salle Medical and Health Sciences Institute located in Rockville, West Visayas State University Medical Center situated in Omaha, Manila Doctors Hospital found in Dasmariñas (plus 8 other sites)."

Answered by AI

Is this medical research recruiting volunteers at the moment?

"According to clinicaltrials.gov, this particular trial is no longer actively recruiting participants; the study was first posted on June 1st 2023 and last updated on May 16th 2023. Nonetheless, there are still 1003 other medical trials searching for patients right now."

Answered by AI

Who else is applying?

What site did they apply to?
Meridian Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
2023. "Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05875961.
All > Infectious Disease > Flu
~225 spots leftby Nov 2024
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