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OpenTrials
Completed

NCT Number: NCT01174849

Pneumococcal Vaccines Early and in Combination

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

28 day–38 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Menzies School of Health Research

Darwin, Northern Territory, 0811, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synflorix

Drug

The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.

Other names: PHiD-CV

Prevenar13

Drug

The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.

Active ingredients

Each 0.5 mL dose contains:

2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg). CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium.

Other names: PCV13

COMBO

Drug

COMBINATION SCHEDULE of vaccine 1 and vaccine 2: Synflorix (PHiD-CV) at 1,2,4 months then Prevenar13 (PCV13) at 6 months of age.

Other names: Combination schedule

Primary outcomes

  1. Immunogenicity

    Time frame: 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 outcomes

  1. nasopharyngeal carriage

    Time frame: 7 months of age

    At 7 months of age, the proportion of children with any carriage of serotype 19A pneumococci

  2. nasopharyngeal carriage

    Time frame: 7 months of age

    At 7 months of age, the proportion of children with any carriage of non-capsular H. influenzae.

  3. otitis media

    Time frame: 7 months of age

    At 7 months of age, the proportion of children with any otitis media.

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Registry information

Official study title

A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes

Acronym: PREVIX_COMBO

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Aug 4, 2010
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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