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

Phase 3

Recruiting

• Conditions: Otitis media in Indigenous infants; Pneumococcal disease; Non-typeable Haemophilus influenzae disease; Ear - Other ear disorders; Infection - Studies of infection and infectious agents; Public Health - Epidemiology

• Registration Number: ACTRN12610000544077
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 425

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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];Serum pneumococcal IgG geometric mean concentration (GMC). Determined by Enzyme Linked Immunosorbent Assay.[7 months of age]

Secondary Outcome Measures

Name	Time	Method
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];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];Proportion of children with any otitis media determined by otoscopy and tympanometry.[7 months of age]