PREVIX_COMBO Primary outcomes
Menzies School of Health ResearchDataset description
Demographics - Location - Ethnicity (all Australian First Nations) Baseline / randomisation characteristics (Table 1 in publication) - Birth characteristics (birth weight, gestational age, maternal smoking) - Randomisation characteristics (weight, age, family history 'runny ears', breastfeeding status, household smoking, environmental smoke) Randomisation allocation (vaccine group) Pneumococcal vaccines given (vaccine type, age at vaccination) Age per visit Immunology - Serotype specific IgG - Protein D ELISA Otitis Media status per visit (age at visit)Identifiers
Source Study
Trial acronym
PREVIX_COMBO
Trial ID
ACTRN12610000544077
Purpose
Prevention
Phase
Phase 3 / Phase 4
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Prof Amanda Leach
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 pneumoco .... Read more
Key Inclusion Criteria
Indigenous infants less than 6 weeks of age, living in a remote community and eligible for pneumococcal vaccination.
Key Exclusion Criteria
less than 32 weeks gestation
Can healthy volunteers participate?
Yes
Population
Sample Size 425
Min. age 4 Weeks
Max. age 6 Weeks
Sex Both males and females
Condition category Non-typeable Haemophilus influenzae disease , Otitis media in Indigenous infants , Pneumococcal disease
Condition code Ear , Infection , Public Health
Intervention
Intervention code Prevention
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.
Comparison
Control group Active
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.
Outcomes
Outcome: 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: 7 months of age
Outcome: Serum pneumococcal IgG geometric mean concentration (GMC). Determined by Enzyme Linked Immunosorbent Assay.Timepoint: 7 months of age