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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12610000544077 |
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Date of registration:
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06/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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. |
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Date of first enrolment:
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28/09/2011 |
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Target sample size:
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425 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12610000544077.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Bio-equivalence;
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Phase:
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Phase 3 / Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof Amanda Leach
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Address:
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Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory
Australia |
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Telephone:
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+61 8 89228196 |
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Email:
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amanda.leach@menzies.edu.au |
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Affiliation:
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Name:
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Prof Amanda Leach
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Address:
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Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory
Australia |
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Telephone:
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+61 8 89228196 |
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Email:
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amanda.leach@menzies.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Indigenous infants less than 6 weeks of age, living in a remote community and eligible for pneumococcal vaccination.
Exclusion criteria: less than 32 weeks gestation
Age minimum:
4 Weeks
Age maximum:
6 Weeks
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Otitis media in Indigenous infants;Pneumococcal disease;Non-typeable Haemophilus influenzae disease;
Otitis media in Indigenous infants
Pneumococcal disease
Non-typeable Haemophilus influenzae disease
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Ear - Other ear disorders
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Public Health - Epidemiology
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Infection - Studies of infection and infectious agents
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Intervention(s)
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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.
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Primary Outcome(s)
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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.[7 months of age]
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Serum pneumococcal IgG geometric mean concentration (GMC). Determined by Enzyme Linked Immunosorbent Assay.[7 months of age]
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Secondary Outcome(s)
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Proportion of children with carriage of serotype 19A pneumococci. Determined by nasal swab and standard microbiological culture for pneumococci. Serotype determined by Quellung reaction.[7 months of age]
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Proportion of children with any otitis media determined by otoscopy and tympanometry.[7 months of age]
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Proportion of children with carriage of Haemophilus influenzae (H. influenzae). Determined by nasal swab and standard microbiological culture for H. influenzae.[7 months of age]
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Secondary ID(s)
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National Health and Medical Research Council (NHMRC) project grant 605810.
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Source(s) of Monetary Support
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National Health and Medical Research Council
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Ethics review
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Status: Approved
Approval date:
Contact:
Human Research Ethics Committee of Northern Territory (NT) Department of Health and Families and Menzies School of Health Research
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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