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Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age

NCT04544267 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-24

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine, high-dose

Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular

BIOLOGICAL

Quadrivalent influenza vaccine, standard dose

Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2021-06-02
Completion
2021-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544267 on ClinicalTrials.gov