PREVIX_COMBO Primary outcomes

Menzies School of Health Research

Dataset 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)
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Source Study


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 ....
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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?




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 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.


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.


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

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see