Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the immunogenicity (antibody response)
      and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of
      Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
    

Detailed description: 
      This study will provide data necessary to evaluate the safety and immunogenicity of Pneumosil
      when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated
      in the Phase 3 pivotal trial (VAC-056; NCT03197376) - namely in a 2 dose primary and booster
      (2+1) schedule - and compare immunogenicity to that of both currently licensed
      second-generation pneumococcal conjugate vaccines (Synflorix and Prevenar 13) administered in
      the same 2+1 schedule.

      In this prospective, single center, randomized, active-controlled, observer-blind, Phase 3
      descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants
      will be randomized 1:1:1 to receive 3 doses of either Pneumosil, Synflorix or Prevenar 13 at
      6 weeks, 14 weeks and 9-10 months of age. Standard Expanded Program on Immunization (EPI)
      vaccinations in The Gambia will be given concomitantly with all 3 doses of study vaccine.

      The booster vaccination window was extended up to 18 months of age due to a pause in the
      study due to the coronavirus disease 2019 (COVID-19) pandemic. The study schedule for
      participants is as follows:

        -  Age 6 weeks: First primary vaccination dose administered

        -  Age 14 weeks: Second primary vaccination dose administered (8 weeks after first primary
           dose)

        -  Age 18 weeks: Blood sample for immunogenicity testing (4 weeks after second primary
           dose)

        -  Age 9-18 months: Blood sample for immunogenicity testing and booster vaccination dose
           administered

        -  Age 10-19 months: Blood sample for immunogenicity testing (4 weeks after booster dose)
    

Intervention name(s): Pneumosil; Prevenar 13; Synflorix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer; One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate; One single dose contains 1 μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
Other intervention name(s): Serum Institute of India Pneumococcal conjugate vaccine (SIIPL-PCV ); Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention