NCT00999206

Brief Summary

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Trial Health

90
On Track

Trial Health Score

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

Enrollment
3,138

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
2 countries

19 active sites

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

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

7 months

First QC Date

October 20, 2009

Last Update Submit

August 25, 2011

Conditions

Influenza

Keywords

InfluenzaVaccineCHMP criteria

Outcome Measures

Primary Outcomes (1)

  • Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase

    3 weeks

Study Arms (4)

1

EXPERIMENTAL
Biological: Influenza Vaccine

2

EXPERIMENTAL
Biological: Influenza Vaccine

3

EXPERIMENTAL
Biological: Influenza Vaccine

4

ACTIVE COMPARATOR
Biological: Influenza Vaccine

Interventions

Influenza VaccineBIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

3

Eligibility Criteria

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

You may qualify if:

  • Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age).
  • Willing and able to give informed consent before any protocol procedures are performed.
  • Able to adhere to visit schedules and all protocol required study procedures.
  • Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

You may not qualify if:

  • Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
  • A serious adverse reaction after a previous (influenza) vaccination.
  • A history of Guillain-Barré syndrome.
  • Known to be allergic to constituents of the study vaccines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Site Reference ID/Investigator# 44652

Adelaide, 5000, Australia

Location

Site Reference ID/Investigator# 44662

Auchenflower, 4066, Australia

Location

Site Reference ID/Investigator# 44651

Blacktown, 2148, Australia

Location

Site Reference ID/Investigator# 44659

Blacktown, 2148, Australia

Location

Site Reference ID/Investigator# 44647

Broadmeadow, 2292, Australia

Location

Site Reference ID/Investigator# 44649

Caboolture, 4510, Australia

Location

Site Reference ID/Investigator# 44646

Carina Heights, 4152, Australia

Location

Site Reference ID/Investigator# 44650

Herston, 4006, Australia

Location

Site Reference ID/Investigator# 44663

Hornsby, 2077, Australia

Location

Site Reference ID/Investigator# 44645

Kippa-Ring, 4020, Australia

Location

Site Reference ID/Investigator# 44644

Malvern East, 3145, Australia

Location

Site Reference ID/Investigator# 44648

Maroubra Junction, 2035, Australia

Location

Site Reference ID/Investigator# 44643

Sherwood, 4075, Australia

Location

Site Reference ID/Investigator# 44653

Christchurch, New Zealand

Location

Site Reference ID/Investigator# 44658

Dunedin, 9012, New Zealand

Location

Site Reference ID/Investigator# 44656

Grafton, 1150, New Zealand

Location

Site Reference ID/Investigator# 44655

Rotorua, 3010, New Zealand

Location

Site Reference ID/Investigator# 44654

Tauranga, 3110, New Zealand

Location

Site Reference ID/Investigator# 44657

Wellington, 6035, New Zealand

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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

NZ(6)AU(13)