Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00999206




Registration number
NCT00999206
Ethics application status
Date submitted
20/10/2009
Date registered
21/10/2009
Date last updated
26/08/2011

Titles & IDs
Public title
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
Scientific title
Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
Secondary ID [1] 0 0
S203.3.013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Influenza Vaccine
Other interventions - Influenza Vaccine
Other interventions - Influenza Vaccine
Other interventions - Influenza Vaccine

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Active Comparator: 4 -


Other interventions: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures

Other interventions: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)

Other interventions: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures

Other interventions: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
Timepoint [1] 0 0
3 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or
elderly >= 61 years of age).

2. Willing and able to give informed consent before any protocol procedures are
performed.

3. Able to adhere to visit schedules and all protocol required study procedures.

4. 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

1. 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).

2. Presence of any significant condition that may prohibit inclusion as determined by the
Investigator.

3. A serious adverse reaction after a previous (influenza) vaccination.

4. A history of Guillain-Barré syndrome.

5. Known to be allergic to constituents of the study vaccines.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
3138
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 44652 - Adelaide
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 44662 - Auchenflower
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 44651 - Blacktown
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 44659 - Blacktown
Recruitment hospital [5] 0 0
Site Reference ID/Investigator# 44647 - Broadmeadow
Recruitment hospital [6] 0 0
Site Reference ID/Investigator# 44649 - Caboolture
Recruitment hospital [7] 0 0
Site Reference ID/Investigator# 44646 - Carina Heights
Recruitment hospital [8] 0 0
Site Reference ID/Investigator# 44650 - Herston
Recruitment hospital [9] 0 0
Site Reference ID/Investigator# 44663 - Hornsby
Recruitment hospital [10] 0 0
Site Reference ID/Investigator# 44645 - Kippa-Ring
Recruitment hospital [11] 0 0
Site Reference ID/Investigator# 44644 - Malvern East
Recruitment hospital [12] 0 0
Site Reference ID/Investigator# 44648 - Maroubra Junction
Recruitment hospital [13] 0 0
Site Reference ID/Investigator# 44643 - Sherwood
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
2148 - Blacktown
Recruitment postcode(s) [4] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [5] 0 0
4510 - Caboolture
Recruitment postcode(s) [6] 0 0
4152 - Carina Heights
Recruitment postcode(s) [7] 0 0
4006 - Herston
Recruitment postcode(s) [8] 0 0
2077 - Hornsby
Recruitment postcode(s) [9] 0 0
4020 - Kippa-Ring
Recruitment postcode(s) [10] 0 0
3145 - Malvern East
Recruitment postcode(s) [11] 0 0
2035 - Maroubra Junction
Recruitment postcode(s) [12] 0 0
4075 - Sherwood
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Grafton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Rotorua
Country [5] 0 0
New Zealand
State/province [5] 0 0
Tauranga
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Biologicals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00999206
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hanka de Voogd, MD
Address 0 0
Abbott Healthcare Products B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00999206