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Trial registered on ANZCTR


Registration number
ACTRN12610000544077
Ethics application status
Approved
Date submitted
5/07/2010
Date registered
6/07/2010
Date last updated
7/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of pneumococcal conjugate vaccines Synflorix and Prevenar13 in sequence or alone in high-risk Indigenous infants (PREV-IX): immunogenicity, carriage and otitis media outcomes
Scientific title
In high-risk Indigenous infants does an early combination schedule of two pneumococcal conjugate vaccines Synflorix and Prevenar13 provide greater pathogen protection than standard single vaccine schedules.
Secondary ID [1] 1581 0
National Health and Medical Research Council (NHMRC) project grant 605810.
Universal Trial Number (UTN)
Trial acronym
PREVIX_COMBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media in Indigenous infants 257104 0
Pneumococcal disease 257705 0
Non-typeable Haemophilus influenzae disease 257706 0
Condition category
Condition code
Ear 257262 257262 0 0
Other ear disorders
Infection 257500 257500 0 0
Studies of infection and infectious agents
Public Health 257876 257876 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Vaccination with Synflorix (intramuscular injection 0.5ml) at 1,2,4 months of age and Prevenar13 at 6 months of age. Final follow up at 7 months of age.
Intervention code [1] 256273 0
Prevention
Comparator / control treatment
1. Vaccination with Prevenar13 (intramuscular injection 0.5ml) at 2,4 and 6 months of age.
2. Vaccination with Synflorix (intramuscular injection 0.5ml)at 2,4 and 6 months of age.
Final follow up at 7 months of age.
Control group
Active

Outcomes
Primary outcome [1] 258166 0
Proportion of infants with serum pneumococcal Immunoglobulin G (IgG) geometric mean concentration (GMC) above threshold (0.35 microg/ml). Determined by Enzyme Linked Immunosorbent Assay.
Timepoint [1] 258166 0
7 months of age
Primary outcome [2] 258167 0
Serum pneumococcal IgG geometric mean concentration (GMC). Determined by Enzyme Linked Immunosorbent Assay.
Timepoint [2] 258167 0
7 months of age
Secondary outcome [1] 263808 0
Proportion of children with carriage of serotype 19A pneumococci. Determined by nasal swab and standard microbiological culture for pneumococci. Serotype determined by Quellung reaction.
Timepoint [1] 263808 0
7 months of age
Secondary outcome [2] 263809 0
Proportion of children with carriage of Haemophilus influenzae (H. influenzae). Determined by nasal swab and standard microbiological culture for H. influenzae.
Timepoint [2] 263809 0
7 months of age
Secondary outcome [3] 263810 0
Proportion of children with any otitis media determined by otoscopy and tympanometry.
Timepoint [3] 263810 0
7 months of age

Eligibility
Key inclusion criteria
Indigenous infants less than 6 weeks of age, living in a remote community and eligible for pneumococcal vaccination.
Minimum age
4 Weeks
Maximum age
6 Weeks
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
less than 32 weeks gestation

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)
Subjects will be sought through antenatal clinics. Staff will ask pregnant women if they are interested in being contacted by Menzies School of Health Research about participating in ear health research. Research staff will contact interested women late in their pregancy for informed consent (Phase I) and again before their baby is 4 weeks of age (Phase II). Consented babies will be allocated to one of the three groups by the National Health and Medical Research Council Clinical Trials Centre, using their phone randomisation service. Allocation concealment will be achieved using this central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be computer generated random number series.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Block randomisation will be used to maintain equal numbers in the 3 groups. We will stratify by place of residence (community).
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,WA
Recruitment postcode(s) [1] 2893 0
0800
Recruitment postcode(s) [2] 7747 0
6743 - Kununurra
Recruitment postcode(s) [3] 7748 0
0822 - Bathurst Island
Recruitment postcode(s) [4] 7749 0
0822 - Wadeye
Recruitment postcode(s) [5] 7750 0
0822 - Maningrida
Recruitment postcode(s) [6] 7751 0
0870 - Alice Springs
Recruitment postcode(s) [7] 7752 0
6430 - Kalgoorlie

Funding & Sponsors
Funding source category [1] 256774 0
Government body
Name [1] 256774 0
National Health and Medical Research Council
Address [1] 256774 0
GPO Box 1421
Canberra ACT 2601
Country [1] 256774 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina
Northern Territory 0811
Country
Australia
Secondary sponsor category [1] 256220 0
Individual
Name [1] 256220 0
Amanda Leach
Address [1] 256220 0
Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811
Country [1] 256220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258796 0
Human Research Ethics Committee of Northern Territory (NT) Department of Health and Families and Menzies School of Health Research
Ethics committee address [1] 258796 0
Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811
Ethics committee country [1] 258796 0
Australia
Date submitted for ethics approval [1] 258796 0
16/06/2010
Approval date [1] 258796 0
25/06/2010
Ethics approval number [1] 258796 0
10/1395

Summary
Brief summary
The bacterium pneumococcus causes invasive disease, pneumonia and otitis media in young children. Seven-valent pneumococcal conjugate vaccine (PCV7) has been provided for Aboriginal and high risk children since 2001 and all Australian children since 2005. There are two new pneumococcal conjugate vaccines to be licensed in Australia by the end of 2010. These have 10 pneumococcal serotypes in common but one also offers protection from H. influenzae infection and the other has 3 additional pneumococcal serotypes. H. influenzae causes otitis media and non-bacteraemic pneumonia but is rarely cultured from blood cultures and thus is considered a less invasive pathogen. For Aboriginal children however, H. influenzae is the major pathogen associated with perforated tympanic membranes (ear drums) and it is thought to be an important cause of pneumonia. Invasive disease caused by the additional serotypes, particularly 19A, has increased in Australian non-indigenous population. Thus it is anticipated that most jurisdictions will choose to use the PCV13. However, because Indigenous children have much higher rates of infection due to H. influenzae than non-Indigenous children, Indigenous children may benefit from both vaccines. There are no studies that directly compare these two vaccines to determine overall clinical benefit. This Randomised Controlled Trial (RCT) will directly compare the two vaccines as well as an early 3+1 combination schedule, commencing at one months of age. Immunological, microbiological and clinical outcomes will be assessed.
Trial website
none
Trial related presentations / publications
Internationl Symposium on Pneumococci and Pneumococcal Diseases, ISPPD7. Tel Aviv March 2010.
Pneumococcal Conjugate Vaccines SynflorIX (PHiD-CV) & PREVenar (13PCV) in combination: PREV-IX_COMBO: A RCT of a mixed early schedule for high-risk infants.
Public notes

Contacts
Principal investigator
Name 31027 0
Prof Amanda Leach
Address 31027 0
Menzies School of Health Research PO Box 41096 Casuarina 0811 Northern Territory
Country 31027 0
Australia
Phone 31027 0
+61 8 89228649
Fax 31027 0
Email 31027 0
Amanda.leach@menzies.edu.au
Contact person for public queries
Name 14274 0
Prof Amanda Leach
Address 14274 0
Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory
Country 14274 0
Australia
Phone 14274 0
+61 8 89228196
Fax 14274 0
+61 8 89275187
Email 14274 0
amanda.leach@menzies.edu.au
Contact person for scientific queries
Name 5202 0
Prof Amanda Leach
Address 5202 0
Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory
Country 5202 0
Australia
Phone 5202 0
+61 8 89228196
Fax 5202 0
+61 8 89275187
Email 5202 0
amanda.leach@menzies.edu.au

No information has been provided regarding IPD availability
Summary results
No Results