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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02765126




Registration number
NCT02765126
Ethics application status
Date submitted
3/05/2016
Date registered
6/05/2016

Titles & IDs
Public title
Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Challenge in the Elderly
Scientific title
Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly
Secondary ID [1] 0 0
H0015460
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heterologous Effects of Vaccines 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Seasonal influenza vaccine
Treatment: Other - Diphtheria-tetanus-acellular pertussis vaccine

Active comparator: Group 1 - Diphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.

Active comparator: Group 2 - Seasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.

Active comparator: Group 3 - Seasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.


Treatment: Other: Seasonal influenza vaccine
Intramuscular standard seasonal influenza vaccine

Treatment: Other: Diphtheria-tetanus-acellular pertussis vaccine
Intramuscular DTaP vaccine
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood
Timepoint [1] 0 0
24 hours, 1 week, 4 weeks and 26 weeks
Secondary outcome [1] 0 0
Whole human genome transcription profile by next generation sequencing in log2 expression levels
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Influenza-specific antibody titres to seasonal influenza vaccination
Timepoint [2] 0 0
4 weeks and 26 weeks
Secondary outcome [3] 0 0
Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL
Timepoint [3] 0 0
24 hours, 1 week, 4 weeks and 26 weeks
Secondary outcome [4] 0 0
Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL
Timepoint [4] 0 0
4 weeks and 26 weeks

Eligibility
Key inclusion criteria
* Two study groups 30-50 years old >65 years old
Minimum age
30 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unwell on day of vaccination
* Temperature >38°C
* Active cancer
* Active autoimmune disease
* Diabetes mellitus
* Taking immunosuppressive drugs including steroids
* Any vaccination in last 3 months
* DT or DTaP vaccination in the last year
* Known allergy or contraindication to influenza or DTaP vaccination
* Pregnant or breastfeeding

Study design
Purpose of the study
Other
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Clifford Craig Foundation - Launceston
Recruitment postcode(s) [1] 0 0
7250 - Launceston

Funding & Sponsors
Primary sponsor type
Other
Name
Clifford Craig Medical Research Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sao Paulo
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Johns Hopkins Bloomberg School of Public Health
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katie Flanagan, PhD FRACP
Address 0 0
Clifford Craig Medical Research Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathryn Ogden, MPH FRACGP
Address 0 0
Country 0 0
Phone 0 0
+61 3 6777 8790
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The transcriptome data will be de-identified and deposited in a pubic database. The de-identified microbiome data may well also be made publically available.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02765126