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Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)

NCT02583256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1601

Last updated 2019-04-24

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. Subjects will receive either the Same or Alternate Type of Vaccine.

Conditions

Interventions

BIOLOGICAL

Adjuvanted QIV (aQIV)

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

BIOLOGICAL

Non-adjuvanted QIV

Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-29
Primary Completion
2016-11-15
Completion
2017-05-09

Countries

  • Finland
  • Philippines
  • Thailand

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 NCT02583256 on ClinicalTrials.gov