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Virus Vaccine

RIV4 cohort for Flu Shot

Phase 3
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 29 or day 57
Awards & highlights

Study Summary

This trial compares the efficacy of two different flu vaccines for 3-8 year olds. It looks at immune response and safety of each.

Eligible Conditions
  • Flu Shot

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 29 or day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 29 or day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Individual Hemagglutination inhibition (HAI) titer at D29 after last vaccination
Percentage of participants achieving seroconversion
Secondary outcome measures
Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
Occurrence of attended adverse event (MAAEs)
Occurrence of immediate adverse events (AEs)
+5 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RIV4 cohortExperimental Treatment1 Intervention
RIV4 single injection at Day 1
Group II: IIV4 cohortActive Control1 Intervention
IIV4, single injection at Day 1

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,615 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
857 Previous Clinical Trials
2,018,933 Total Patients Enrolled

Media Library

Quadrivalent influenza vaccine (IIV4) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05513391 — Phase 3
Flu Shot Research Study Groups: IIV4 cohort, RIV4 cohort
Flu Shot Clinical Trial 2023: Quadrivalent influenza vaccine (IIV4) Highlights & Side Effects. Trial Name: NCT05513391 — Phase 3
Quadrivalent influenza vaccine (IIV4) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513391 — Phase 3
Flu Shot Patient Testimony for trial: Trial Name: NCT05513391 — Phase 3

Frequently Asked Questions

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

Has the RIV4 cohort been approved by the Food and Drug Administration?

"We rate the safety of this RIV4 cohort at a 3, due to its Phase 3 status. There is prior evidence that suggests it both effective and safe."

Answered by AI

Are there any qualifications for participating in this clinical experiment?

"To be eligible to participate in this trial, candidates must possess up-to-date influenza vaccination records and be aged between 3 and 8. Approximately 1412 patients will ultimately be recruited for the study."

Answered by AI

Does this research include participants aged twenty or more?

"According to the trial's inclusion requirements, only those between 3 and 8 years of age are eligible for participation."

Answered by AI

Is this experiment still recruiting participants?

"As of now, the clinical trial is actively recruiting. Data on clinicialtrials.gov shows that this medical study was first posted November 10th 2022 and subsequently updated 18 days later."

Answered by AI

What is the total enrollment capacity of this medical experiment?

"Affirmative, clinicaltrials.gov confirms that this experimental research is actively recruiting candidates. This project was initially uploaded on November 10th 2022 and has since been amended as of the 18th of the same month. 1412 participants are required from 2 different locations for successful completion."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Research Foundation-Site Number:8400003
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I just want to do a clinical trial to help with research,to give back and pay off some bills kinda kill 2 birds with 1 stone so to speak!
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
2022. "Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05513391.
~151 spots leftby Apr 2025
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