Pneumococcal Vaccines Early and in Combination (PREVIX_COMBO)

Menzies School of Health Research

Status and phase: Completed; Phase 4

Conditions: Otitis Media

Treatments: Drug: Synflorix; Drug: Prevenar13; Drug: COMBO

Study type: Interventional

Funder types: Other

Identifiers

NCT01174849

ACTRN12610000544077 (Registry Identifier)

605810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 425 patients

Sex: All

Ages: 28 to 38 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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425 participants in 3 patient groups

Synflorix

Active Comparator group

Treatment:

Drug: Synflorix

Prevenar13

Active Comparator group

Treatment:

Drug: Prevenar13

COMBO

Experimental group

Description:

COMBINATION SCHEDULE of comparator vaccine 1 and comparator vaccine 2 Synflorix at 1,2,4 months then Prevenar13 at 6 months.

Treatment:

Drug: COMBO