NCT01013675

Brief Summary

A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

12 active sites

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

November 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

1.4 years

First QC Date

November 13, 2009

Last Update Submit

October 26, 2011

Conditions

Influenza Vaccines

Keywords

influenzaactive-controlledPhase 2

Outcome Measures

Primary Outcomes (3)

  • To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.

    3 weeks

  • To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.

    6 months

  • To assess the safety and tolerability of the cell-derived vaccine following revaccination.

    6 months

Secondary Outcomes (2)

  • To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.

    3 weeks

  • To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.

    6 months

Study Arms (2)

1

EXPERIMENTAL

15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose

Biological: Influenza Vaccine

2

ACTIVE COMPARATOR

15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose

Biological: Influenza Vaccine

Interventions

Influenza VaccineBIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

1

Eligibility Criteria

Age61 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  • Men and women (elderly)
  • Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

You may not qualify if:

  • Known to be allergic to constituents of the vaccine.
  • Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site Reference ID/Investigator# 45005

Benátky nad Jizerou, 294 71, Czechia

Location

Site Reference ID/Investigator# 45004

Hradec Králové, 500 03, Czechia

Location

Site Reference ID/Investigator# 45007

Paide, 72713, Estonia

Location

Site Reference ID/Investigator# 45012

Saku, 75501, Estonia

Location

Site Reference ID/Investigator# 45009

Tallinn, 10617, Estonia

Location

Site Reference ID/Investigator# 45010

Tallinn, 10617, Estonia

Location

Site Reference ID/Investigator# 45013

Tartu, 51014, Estonia

Location

Site Reference ID/Investigator# 45017

Kaunas, 47144, Lithuania

Location

Site Reference ID/Investigator# 45015

Kaunas, 48259, Lithuania

Location

Site Reference ID/Investigator# 45016

Kaunas, 49456, Lithuania

Location

Site Reference ID/Investigator# 45018

Kaunas, 50009, Lithuania

Location

Site Reference ID/Investigator# 45019

Klaipėda, 92231, Lithuania

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

  • Hanka de Voogd, MD

    Abbott Healthcare Products B.V

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

LI(5)ES(5)CZ(2)