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Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

NCT ID: NCT00408395

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

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This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

Detailed Description

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A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Conditions

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Influenza

Keywords

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influenza children vaccine influenza disease

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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1: Trivalent Seasonal Influenza Vaccine

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

Seasonal Influenza Vaccine

2: Adjuvanted Trivalent Seasonal Influenza Vaccine

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type BIOLOGICAL

Seasonal Influenza Vaccine

Interventions

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Influenza vaccine

Seasonal Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 6 months to \< 36 months of age

Exclusion Criteria

* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
* Known or suspected impairment/alteration of immune function
* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 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

Principal Investigators

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Novartis Vaccines (formerly Chiron Vaccines)

Role: STUDY_CHAIR

Novartis

Locations

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University of Tampere Medical School

Tampere, , Finland

Site Status

Countries

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Finland

References

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Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394.

Reference Type RESULT
PMID: 19561422 (View on PubMed)

Other Identifiers

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2006-003181-34

Identifier Type: -

Identifier Source: secondary_id

V70P2

Identifier Type: -

Identifier Source: org_study_id