Reduced PCV Dosing Schedules in South African Infants
Condition: Pneumonia; Meningitis
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal
      Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at
      either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule),
      and compare this immune response to those who receive a two dose primary series (at 6 and 14
      weeks of age) and booster dose at 9-months (2+1 schedule).
    

Detailed description: 
      Pneumonia is the leading global cause of childhood death outside of the neonatal period, and
      contributes to 19% of the 10 million childhood deaths occurring annually, the majority of
      which occurs in industrialising countries. Despite the successes in improving primary
      healthcare in South Africa since 1994, pneumonia nevertheless remains a leading cause of
      childhood death in South Africa, aggravated by the HIV/AIDS epidemic. Streptococcus
      pneumoniae is recognised as the leading bacterial cause of pneumonia in children as well as
      having been identified as a common cause of super-imposed bacterial infection in individuals
      with respiratory virus-associated pneumonia.

      In South Africa, the cost of procurement of PCV ($20 per dose) totals almost 50% of the total
      cost of all vaccines purchased for the national immunisation program. Similarly, PCV is the
      most expensive vaccine purchased by the Global Alliance for Vaccines and Immunisation (GAVI),
      which heavily funds vaccine procurement for low income countries. The sustainability of
      continued procurement of this vaccine at the current pricing in low-middle income countries
      remains uncertain.

      This will be a randomized, open-label study (laboratory personnel will however be blinded) in
      which subjects are randomized to one of two (primary dose at either 6 or 14 weeks of age) 1+1
      dosing schedules of PCV10 or PCV13, or to a 2+1 schedule of these vaccines. A total of 600
      subjects will be randomized in a 1:1:1:1:1:1 ratio to one of the six groups. The study will
      be undertaken at an experienced research site in Johannesburg, South Africa, where the 600
      children born to HIV-uninfected women are expected to be enrolled over a 12- month period.
    

Intervention name(s): Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks; Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks; Pneumococcal conjugate vaccine (PCV10 ) 2+1; Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeks; Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeks; Pneumococcal conjugate vaccine (PCV13 ) 2+1
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): PCV10 1+1, 6 weeks & 9 months; PCV10 1+1, 14 weeks & 9 months; PCV10 2+1, 6&14 weeks & 9 months; PCV13 1+1, 6 weeks & 9 months; PCV13 1+1, 14 weeks & 9 months; PCV13 2+1, 6&14 weeks & 9 months
Other intervention name(s): Synflorix (PCV10); Synflorix (PCV10); Synflorix (PCV10); Prevenar 13; Prevenar 13; Prevenar 13
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity