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Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

NCT03698279 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2022-04-04

Study results available
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Summary

The objectives of this study were:

* To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study).
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method.
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.
* To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.

Conditions

Interventions

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

BIOLOGICAL

Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)

Pharmaceutical form: Solution for injection Route of administration: IM

BIOLOGICAL

FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)

Pharmaceutical form: Solution for injection Route of administration: IM

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
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2019-10-16
Completion
2019-10-16
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT03698279 on ClinicalTrials.gov