Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Influenza

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Children, Vaccine

Eligibility Criteria

6 Months - 35 Months (Child)All Sexes

Inclusion Criteria: children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry 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, 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

Sites / Locations

University of Tampere Medical School

Outcomes

Primary Outcome Measures

Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.

Secondary Outcome Measures

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Full Information

NCT ID

NCT00311428

First Posted

April 3, 2006

Last Updated

September 13, 2006

Sponsor

Novartis

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00311428

Brief Title

Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

Official Title

A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Children, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

270 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Influenza

Primary Outcome Measure Information:

Title

Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.

Secondary Outcome Measure Information:

Title

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Eligibility Criteria

Inclusion Criteria: children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry 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, 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines Information Services

Organizational Affiliation

Novartis Vaccines & Diagnostics

Official's Role

Study Chair

Facility Information:

Facility Name

University of Tampere Medical School

City

Tampere

Country

Finland

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial