MedDataX Logo

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

NCT ID: NCT00311428

Last Updated: 2006-09-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Influenza Children Vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Influenza

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Vaccines Information Services

Role: STUDY_CHAIR

Novartis Vaccines & Diagnostics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Tampere Medical School

Tampere, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUDRACT: 2004-001952-35

Identifier Type: -

Identifier Source: secondary_id

M71P1

Identifier Type: -

Identifier Source: org_study_id