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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

NCT ID: NCT01342796

Last Updated: 2021-04-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Influenza Influenza Influenza Due to Unspecified Influenza Virus Human Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Group Type EXPERIMENTAL

MF59C.1-adjuvanted subunit influenza vaccine

Intervention Type BIOLOGICAL

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

Arm 2

Group Type ACTIVE_COMPARATOR

Sub unit, Inactivated, Influenza vaccine

Intervention Type BIOLOGICAL

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

Interventions

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MF59C.1-adjuvanted subunit influenza vaccine

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

Intervention Type BIOLOGICAL

Sub unit, Inactivated, Influenza vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female previously unvaccinated healthy children aged 6 to \<36 months.

Exclusion Criteria

* Any known or suspected impairment of the immune system, any serious disease.
* Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
* Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 21: GZA campus Sint Vincentius

Antwerp, , Belgium

Site Status

Site 22: Kinderartsenpraktijk

Hasselt, , Belgium

Site Status

Countries

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Belgium

References

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Zedda L, Forleo-Neto E, Vertruyen A, Raes M, Marchant A, Jansen W, Clouting H, Arora A, Beatty ME, Galli G, Del Giudice G, Castellino F. Dissecting the immune response to MF59-adjuvanted and nonadjuvanted seasonal influenza vaccines in children less than three years of age. Pediatr Infect Dis J. 2015 Jan;34(1):73-8. doi: 10.1097/INF.0000000000000465.

Reference Type DERIVED
PMID: 25037034 (View on PubMed)

Other Identifiers

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2010-023791-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V70_34

Identifier Type: -

Identifier Source: org_study_id

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