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Efficacy Study With QIVc in Pediatric Subjects

NCT03932682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5723

Last updated 2025-03-04

Study results available
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Summary

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

QIVc

QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.

BIOLOGICAL

Comparator

Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

Sponsors & Collaborators

  • 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
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2023-11-30
Completion
2024-02-13
FDA Drug
Yes

Countries

  • Bangladesh
  • Bulgaria
  • Czechia
  • Estonia
  • Honduras
  • Latvia
  • Malaysia
  • New Zealand
  • Pakistan
  • Philippines
  • Poland
  • Romania
  • South Africa
  • Thailand
  • Ukraine

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 NCT03932682 on ClinicalTrials.gov