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Trial registered on ANZCTR


Registration number
ACTRN12614000354684
Ethics application status
Approved
Date submitted
19/03/2014
Date registered
2/04/2014
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted enhanced surveillance to observe vaccine impact against Pneumococcus
Scientific title
Evaluation of the effectiveness of the 13-valent pneumococcal conjugate vaccine against pneumococcal pneumonia in children
Secondary ID [1] 284253 0
Nil
Universal Trial Number (UTN)
Trial acronym
TESTOV-Pneumo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 291369 0
Streptococcus pneumoniae 291371 0
Empyema 291412 0
Condition category
Condition code
Infection 291735 291735 0 0
Studies of infection and infectious agents
Respiratory 291736 291736 0 0
Other respiratory disorders / diseases
Public Health 291857 291857 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pneumonia caused by Streptococcus pneumoniae is a leading cause of childhood morbidity and mortality. While vaccination programs against pneumococcus are highly effective in reducing invasive pneumococcal disease, there are concerns that they may lead to serotype replacement disease; a phenomenon which has been reported in children with empyema, a complication of pneumonia. This study will assess the effectiveness of the 13-valent pneumococcal conjugate vaccine (13vPCV) program (which includesadministration of 13vPCV to children and 2, 4 and 6 months, and an 18 month booster for Aboriginal and Torres Strait Islander children residing in the NT) on hospitalised childhood pneumonia over 3 years. This study will also assess the bacterial and associated viral causes of pneumonia and empyema in children in Australia.
Intervention code [1] 288992 0
Not applicable
Comparator / control treatment
vaccine effectiveness will be estimated using a matched case-control analysis of PCV eligible children. For every case of SP pneumonia identified in this study, one or more date-of-birth and postcode-matched controls will be sampled from a de-identified Australian Childhood Immunisation Registry (ACIR) dataset
Control group
Active

Outcomes
Primary outcome [1] 291704 0
Determine the real-world effectiveness of pneumococcal conjugate vaccine for preventing hospitalisation for Streptococcus pneumoniae (SP) confirmed and all-cause pneumonia; by testing patient blood, nasopharyngeal and pleural fluid samples to identify SP and perform further molecular testing to determine the isolates specific serotype. To determine vaccine effectiveness, idetified serotypes will be compared to those present in the current 13vPCV.
Timepoint [1] 291704 0
At completion of the observational study (36 months)
Secondary outcome [1] 307331 0
To determine the contribution of SP to complicated and uncomplicated pneumonia in Australian children following the introduction of 13vPCV. All subjects recruited with complicated or un-complicated pneumonia will have blood and nasopharyngeal samples, +/- pleural fluid samples tested for the presence of Streptococcus pneumoniae (SP) along with other commom bacteria and viruses. SP positive samples will be further tested to identify specific PCV or non-PCV serotypes.
Timepoint [1] 307331 0
At the completion of the observational study (36 months)
Secondary outcome [2] 307501 0
To assess SP serotype replacement by comparing the distribution of serotypes causing complicated and uncomplicated SP pneumonia with those obtained for complicated pneumonia before the introduction of 13vPCV.
Timepoint [2] 307501 0
At the completion of the observational study (36 months)
Secondary outcome [3] 307502 0
To determine the contribution of non-SP bacterial causes of complicated childhood pneumonia.
Culture of Blood +/- pleural fluid samples will be performed at each participating site as per hospital operating procedures. Specific molecular testing will occur using in-house PCR's to detect non-SP bacteria such as Haemophilus influenzae, MSSA & MRSA
Timepoint [3] 307502 0
At the completion of the observational study (36 months)
Secondary outcome [4] 307503 0
To determine the contribution of infection with respiratory viruses to pneumonia in children, and to assess the role of viral co-infection in pneumococcal pneumonia.
Nasopharyngeal samples from patients with complicated and un-complicated pneumonia will be cultured on enhanced growth medium to identify SP and other pathogens.
Timepoint [4] 307503 0
At the completion of the observational study (36 months)

Eligibility
Key inclusion criteria
1. Children < 18 years old hospitalized <24 hours
2. Xray confirmed pneumonia
3. Presumed infective aetiology
4. A full blood count performed and at least 250microL of blood in an EDTA tube available for further testing.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant co-morbidity, including haematologic malignancy, post stem cell or solid organ transplantation, cystic fibrosis, congenital malformation of the lung
2. Hospitalised within 14 days of presentation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
The distribution of SP serotypes among empyema cases for the 7vPCV (from ARNiE) and 13vPCV periods will be compared using two-tailed chi square statistic or Fisher’s exact test for contingency tables.

The vaccination status of cases and each of its matched controls will be referenced with regard to the date of hospitalisation of the case. The vaccination status of each case (0 doses, 1 dose, 2 doses, or 3 or more doses) will be compared with that of matched controls using conditional logistic regression analysis to estimate the odds ratio of vaccination for cases versus controls. VE will be inferred from the odds ratio (ie. VE = 1 – OR*100%) with 95% confidence intervals. VE will be estimated separately for:
1. complicated SP pneumonia (empyema),
2. uncomplicated SP PwiRIM, and
3. uncomplicated SP PwoRIM.
If the absolute difference in the point estimates of VE is <20%, the VE analyses will be pooled and reported as the primary VE measure, otherwise VE estimates will be reported separately as the primary VE measure.
Secondary VE estimates will be calculated for:
1. all pneumonia
2. PCV-type SP pneumonia, and
3. non-PCV-type SP pneumonia.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 2194 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 2195 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 2196 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 2197 0
Royal Children's Hospital - Herston
Recruitment hospital [5] 2199 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [6] 2200 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [7] 2201 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [8] 2202 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [9] 2203 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 2204 0
The Canberra Hospital - Garran
Recruitment hospital [11] 2205 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [12] 2206 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [13] 8400 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 7871 0
2031 - Randwick
Recruitment postcode(s) [2] 7872 0
6008 - Subiaco
Recruitment postcode(s) [3] 7873 0
2145 - Westmead
Recruitment postcode(s) [4] 7875 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [5] 7876 0
4101 - South Brisbane
Recruitment postcode(s) [6] 7877 0
0811 - Casuarina
Recruitment postcode(s) [7] 7878 0
5006 - North Adelaide
Recruitment postcode(s) [8] 7879 0
3052 - Parkville
Recruitment postcode(s) [9] 7881 0
2305 - New Lambton Heights
Recruitment postcode(s) [10] 7882 0
7000 - Hobart
Recruitment postcode(s) [11] 7883 0
2605 - Garran
Recruitment postcode(s) [12] 7884 0
3168 - Clayton
Recruitment postcode(s) [13] 7885 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 288909 0
Government body
Name [1] 288909 0
National Health Medical Research Council project grant (1064841)
Country [1] 288909 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 287605 0
Individual
Name [1] 287605 0
Professor Adam Jaffe
Address [1] 287605 0
School of Women's and Children's Health
Level 3 Sydney Children's Hospital
High Street, Randwick 2031 NSW
Country [1] 287605 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290739 0
Hunter New England Local Health District
Ethics committee address [1] 290739 0
Ethics committee country [1] 290739 0
Australia
Date submitted for ethics approval [1] 290739 0
30/04/2014
Approval date [1] 290739 0
31/07/2014
Ethics approval number [1] 290739 0
EC00130
Ethics committee name [2] 298012 0
Mater Health Services HUman Research Ethics Committee
Ethics committee address [2] 298012 0
Ethics committee country [2] 298012 0
Australia
Date submitted for ethics approval [2] 298012 0
17/06/2014
Approval date [2] 298012 0
08/08/2014
Ethics approval number [2] 298012 0
EC00332
Ethics committee name [3] 298013 0
Monash Health Human Research Ethics Committee
Ethics committee address [3] 298013 0
Ethics committee country [3] 298013 0
Australia
Date submitted for ethics approval [3] 298013 0
08/07/2014
Approval date [3] 298013 0
24/02/2015
Ethics approval number [3] 298013 0
14247B
Ethics committee name [4] 298014 0
WCHN Human Research Ethics Committee
Ethics committee address [4] 298014 0
Ethics committee country [4] 298014 0
Australia
Date submitted for ethics approval [4] 298014 0
12/08/2014
Approval date [4] 298014 0
01/11/2014
Ethics approval number [4] 298014 0
HREC/14/WCHN/92
Ethics committee name [5] 298015 0
Central Austrailia Human Research Ethics Committee
Ethics committee address [5] 298015 0
Ethics committee country [5] 298015 0
Australia
Date submitted for ethics approval [5] 298015 0
12/06/2014
Approval date [5] 298015 0
01/08/2014
Ethics approval number [5] 298015 0
14-247
Ethics committee name [6] 298016 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzie School of Research
Ethics committee address [6] 298016 0
Ethics committee country [6] 298016 0
Australia
Date submitted for ethics approval [6] 298016 0
20/05/2014
Approval date [6] 298016 0
18/08/2014
Ethics approval number [6] 298016 0
2014-2219
Ethics committee name [7] 298017 0
Princess Margaret Hospital for Children HREC
Ethics committee address [7] 298017 0
Ethics committee country [7] 298017 0
Australia
Date submitted for ethics approval [7] 298017 0
14/08/2014
Approval date [7] 298017 0
18/12/2014
Ethics approval number [7] 298017 0
2014097EP
Ethics committee name [8] 298018 0
ACT Human Research Ethics Committee
Ethics committee address [8] 298018 0
Ethics committee country [8] 298018 0
Australia
Date submitted for ethics approval [8] 298018 0
17/08/2015
Approval date [8] 298018 0
26/11/2015
Ethics approval number [8] 298018 0
ETH.9.15.161
Ethics committee name [9] 298019 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [9] 298019 0
Ethics committee country [9] 298019 0
Australia
Date submitted for ethics approval [9] 298019 0
10/02/2015
Approval date [9] 298019 0
05/05/2015
Ethics approval number [9] 298019 0
H0014697

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

Contacts
Principal investigator
Name 46898 0
Prof Adam Jaffe
Address 46898 0
Level 3 Sydney Children's Hospital
School of Women's and Children's Health
High Street, Randwick 2031 NSW
Country 46898 0
Australia
Phone 46898 0
+612 93821799
Fax 46898 0
Email 46898 0
adam.jaffe@unsw.edu.au
Contact person for public queries
Name 46899 0
Roxanne Strachan
Address 46899 0
Level 0, Ainsworth Building, South West Wing
Sydney Children's Hospital
High Street Randwick 2031 NSW
Country 46899 0
Australia
Phone 46899 0
+61293820639
Fax 46899 0
Email 46899 0
roxanne.strachan@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 46900 0
Adam Jaffe
Address 46900 0
Level 3 Sydney Children's Hospital
School of Women's and Children's Health
High Street, Randwick 2031 NSW
Country 46900 0
Australia
Phone 46900 0
+61293821799
Fax 46900 0
Email 46900 0
adam.jaffe@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo results not analysed yet

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessing the impact of the 13 valent pneumococcal vaccine on childhood empyema in Australia.2021https://dx.doi.org/10.1136/thoraxjnl-2020-216032
EmbaseReal world impact of 13vPCV in preventing invasive pneumococcal pneumonia in Australian children: A national study.2023https://dx.doi.org/10.1016/j.vaccine.2022.11.006
N.B. These documents automatically identified may not have been verified by the study sponsor.