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Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

NCT03143101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-12-11

Study results available
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Summary

This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.

Conditions

Interventions

BIOLOGICAL

FluMist trivalent (2015-2016)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

BIOLOGICAL

FluMist Quadrivalent (2015-2016)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

BIOLOGICAL

FluMist Quadrivalent (2017-2018)

0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10\^7±0.5 FFU of each vaccine strain.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2017-09-29
Completion
2017-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03143101 on ClinicalTrials.gov