Pneumococcal Vaccines Early and in Combination

Phase 4

Completed

• Conditions: Otitis Media
• Interventions: Drug: Synflorix; Drug: Prevenar13; Drug: COMBO

• Registration Number: NCT01174849
• Lead Sponsor: Menzies School of Health Research

Brief Summary

The purpose of this study is to determine whether an early schedule of a combination of three doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or PHiD-CV.

Detailed Description

Aboriginal children in the Northern Territory (NT) have high rates of otitis media caused by non-capsular H. influenzae (NCHi) and pneumococci. Pneumococcal conjugate vaccine has effectively reduced disease caused by the 7 serotypes. Rates of non-vaccine serotype otitis media (OM), particularly 19A is increasing, and NCHi continues to be a major pathogen in perforations. Parallels with pneumonia are highly probable in this population. Vaccines with expanded and early age protection are needed.

In early 2009 GSK's pneumococcal H. influenzae protein D conjugate vaccine (PHiD-CV) was licensed in Australia. Compared to the current vaccine, 7PCV, this vaccine offers protection from pneumococcal serotypes 1, 5, 7F as well as NCHi (which is a primary pathogen of OM, and possibly pneumonia). However by 2010, a new generation of Wyeth's 7PCV, PCV13 will also be licensed in Australia. Compared to PHiD-CV this vaccine offers protection from additional serotypes 3, 6A and 19A, however it does not offer protection from NCHi infection. There is no empirical evidence to suggest that either vaccine will have superior clinical efficacy for otitis media or pneumonia in high-risk children. The novel combination strategy proposed for this trial has the potential to provide the best of both vaccines.

Study Timeline

• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Study Start: 2011-08
• Primary Completion: 2017-09-21
• Study Completion: 2018-03-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

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

Inclusion Criteria

Indigenous infants

• 4 to 6 weeks of age
• Living in remote communities that have provided signed Expressions of Interest in participating in PREV-IX_COMBO trial
• Intend to remain in their community until their baby is 7 months of age
• Eligible for routine vaccinations.

Exclusion Criteria

• Prior adverse reaction to pneumococcal conjugate vaccines according to Australian Immunization Handbook.
• Gestational age < 32 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synflorix	Synflorix	-
Prevenar13	Prevenar13	-
COMBO	COMBO	COMBINATION SCHEDULE of comparator vaccine 1 and comparator vaccine 2 Synflorix at 1,2,4 months then Prevenar13 at 6 months.

Primary Outcome Measures

Name	Time	Method
Immunogenicity	7 months of age	At 7 months of age, the overall and serotype specific (particularly serotype 19A and HiD) a IgG Geometric Mean Concentration (GMC) b proportion of children with IgG GMC above threshold (0.35 microg/mL)

Secondary Outcome Measures

Name	Time	Method
nasopharyngeal carriage	7 months of age	At 7 months of age, the proportion of children with any carriage of non-capsular H. influenzae.
otitis media	7 months of age	At 7 months of age, the proportion of children with any otitis media.

Trial Locations

Locations (1)

Menzies School of Health Research; 🇦🇺 Darwin, Northern Territory, Australia