NCT00518453

Brief Summary

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

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

July 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

August 17, 2007

Last Update Submit

November 30, 2016

Conditions

Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • evaluate the antibody response to each influenza vaccine antigen

    21 days post-immunization

Secondary Outcomes (1)

  • Safety and tolerability of the study vaccine in the study population

    Throughout the study

Study Arms (1)

Arm 1: Fluvirin

EXPERIMENTAL
Biological: Surface antigen inactivated influenza vaccine

Interventions

Surface antigen inactivated influenza vaccineBIOLOGICAL

1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Arm 1: Fluvirin

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

You may not qualify if:

  • Any serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Health Centre

Suffolk, United Kingdom

Location

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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 20, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 1, 2016

Record last verified: 2011-11

Locations

GB(1)