A phase II, randomized, controlled, partially-blind study to demonstrate immunogenicity and assess safety of GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccines (2830929A and 2830930A) administered as a 3-dose primary vaccination course during the first 6 months of life and as a booster dose at 12-15 months of age.

Trial Profile

A phase II, randomized, controlled, partially-blind study to demonstrate immunogenicity and assess safety of GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccines (2830929A and 2830930A) administered as a 3-dose primary vaccination course during the first 6 months of life and as a booster dose at 12-15 months of age.

Completed
Phase of Trial: Phase II

Latest Information Update: 07 Jul 2017

At a glance

  • Drugs GSK 2830929A (Primary) ; GSK 2830930A (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Pneumococcal 10-valent vaccine conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Hepatitis B; Influenza B virus infections; Pertussis; Pneumonia; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Acronyms SPNG-009
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 25 Apr 2017 Results (n=890) assessing differences in immune responses to PCV13 and PCV10 using patient data from NCT01204658, NCT01616459 and NTR3069 trials, presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases
    • 06 Mar 2014 According to the ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
    • 09 Aug 2013 Planned End Date changed from 1 Dec 2013 to 1 Jan 2014 as reported by ClinicalTrials.gov.
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