NCT00311428

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

April 3, 2006

Last Update Submit

September 13, 2006

Conditions

Influenza

Keywords

InfluenzaChildrenVaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

InfluenzaBIOLOGICAL

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tampere Medical School

Tampere, Finland

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Novartis Vaccines Information Services

    Novartis Vaccines & Diagnostics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 6, 2006

Study Start

October 1, 2005

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

FI(1)