Pneumococcal Vaccines Early and in Combination
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Synflorix; Prevenar13; COMBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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 intervention name(s): PHiD-CV; PCV13; Combination schedule
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: otitis media; pneumococcal vaccines; randomised controlled trial; high-risk children; indigenous; Australia