NCT00848887

Brief Summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

February 19, 2009

Last Update Submit

January 23, 2014

Conditions

Influenza

Keywords

InfluenzaFluVaccineAdjuvant

Outcome Measures

Primary Outcomes (1)

  • Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.

    50 days

Secondary Outcomes (1)

  • Strain-specific influenza antibody titers will be used to assess Immunogenicity

    50 days

Study Arms (1)

1

EXPERIMENTAL
Biological: Adjuvanted and un-adjuvanted influenza vaccines

Interventions

Adjuvanted and un-adjuvanted influenza vaccinesBIOLOGICAL

16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

1

Eligibility Criteria

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

You may qualify if:

  • Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

You may not qualify if:

  • History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL St. Luc - Pharmacy

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.

    PMID: 21906647RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

BE(1)