Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
Public ClinicalTrials.gov record NCT04544267. 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
Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type. The secondary objectives of the study were: * To compare QIV-HD to QIV-SD: * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold * in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine. * in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types. * To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age * To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response * To describe the immune response to revaccination in Season 3 (Northern Hemisphere) * To describe the safety profile of each vaccine
Study identification
- NCT ID
- NCT04544267
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Quadrivalent influenza vaccine, high-dose Biological
- Quadrivalent influenza vaccine, standard dose Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 35 Months
- 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
- Sep 15, 2020 (Actual)
- Primary completion
- Jun 2, 2021 (Actual)
- Completion
- Jun 2, 2021 (Actual)
- Last update posted
- Dec 24, 2025
2020 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Research Foundation Site Number : 8400008 | San Diego | California | 92123-1881 | — |
| Acevedo Clinical Research Associates Site Number : 8400007 | Miami | Florida | 33142 | — |
| Emory Childrens Center- Site Number : 8400001 | Atlanta | Georgia | 30322 | — |
| Heartland El Dorado- Site Number : 8400032 | El Dorado | Kansas | 67042 | — |
| Kentucky Pediatrics / Adult Research- Site Number : 8400005 | Bardstown | Kentucky | 40004 | — |
| Velocity Clinical Research- New Orleans Site Number : 8400009 | New Orleans | Louisiana | 70119 | — |
| Ohio Pediatric Research- Site Number : 8400027 | Dayton | Ohio | 45414 | — |
| Rainbow Pediatrics- Site Number : 8400033 | Barnwell | South Carolina | 29812 | — |
| Cenexel JBR- Site Number : 8400006 | Salt Lake City | Utah | 84107 | — |
| Foothill Family Clinic South- Site Number : 8400045 | Salt Lake City | Utah | 84121 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04544267, 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 Dec 24, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04544267 live on ClinicalTrials.gov.