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Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

NCT01342796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-04-19

Study results available
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Summary

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to \<36 months.

Conditions

Interventions

BIOLOGICAL

MF59C.1-adjuvanted subunit influenza vaccine

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

BIOLOGICAL

Sub unit, Inactivated, Influenza vaccine

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Belgium

Study Locations

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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 NCT01342796 on ClinicalTrials.gov