Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
Public ClinicalTrials.gov record NCT05513391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
Study identification
- NCT ID
- NCT05513391
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 366 participants
Conditions and interventions
Conditions
Interventions
- Recombinant influenza vaccine (RIV4) Biological
- Quadrivalent influenza vaccine (IIV4) Biological
Biological
Eligibility (public fields only)
- Age range
- 3 Years to 8 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2022 (Actual)
- Primary completion
- Oct 3, 2023 (Actual)
- Completion
- Oct 3, 2023 (Actual)
- Last update posted
- Sep 9, 2025
2022 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pediatric Associates Site Number : 8400023 | Birmingham | Alabama | 35205 | — |
| The Children's Clinic Of Jonesboro PA Site Number : 8400025 | Jonesboro | Arkansas | 72401 | — |
| California Research Foundation Site Number : 8400003 | San Diego | California | 92123-1881 | — |
| Meridian Clinical Research- Sioux City Site Number : 8400007 | Sioux City | Iowa | 51106 | — |
| AMR - Newton Site Number : 8400021 | Newton | Kansas | 67114 | — |
| Kentucky Pediatrics / Adult Research Site Number : 8400010 | Bardstown | Kentucky | 40004 | — |
| Velocity Clinical Research- New Orleans Site Number : 8400012 | New Orleans | Louisiana | 70119 | — |
| Velocity Clinical Research Lincoln Site Number : 8400013 | Lincoln | Nebraska | 68510 | — |
| Velocity Clinical Research Omaha Site Number : 8400009 | Omaha | Nebraska | 68134 | — |
| Meridian Clinical Research Site Number : 8400006 | Binghamton | New York | 13905 | — |
| Velocity Clinical Research Vestal Site Number : 8400016 | Vestal | New York | 13850 | — |
| Ohio Pediatric Research Site Number : 8400020 | Dayton | Ohio | 45414 | — |
| Rainbow Pediatrics Site Number : 8400014 | Barnwell | South Carolina | 29812 | — |
| Coastal Pediatric Research Charleston Site Number : 8400005 | Charleston | South Carolina | 29414 | — |
| Coastal Carolina Research Center Site Number : 8400022 | North Charleston | South Carolina | 29405 | — |
| JBR Clinical Research Site Number : 8400001 | Salt Lake City | Utah | 84107 | — |
| J. Lewis Research Site Number : 8400017 | Salt Lake City | Utah | 84109 | — |
| Alliance for Multispecialty Research Syracuse Site Number : 8400027 | Syracuse | Utah | 84075-9645 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05513391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05513391 live on ClinicalTrials.gov.