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Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

NCT01964989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10644

Last updated 2023-03-27

Study results available
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Summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Conditions

  • Influenza Virus

Interventions

BIOLOGICAL

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

BIOLOGICAL

Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-10-31
Completion
2016-08-31

Countries

  • United States
  • Canada
  • Finland
  • Italy
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Spain
  • Taiwan
  • Thailand

Study Locations

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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 NCT01964989 on ClinicalTrials.gov