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Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

NCT02255409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2023-03-15

Study results available
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Summary

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05

Conditions

Interventions

BIOLOGICAL

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

BIOLOGICAL

non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Finland

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 NCT02255409 on ClinicalTrials.gov