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A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals' Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age.

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Trial Profile

A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals' Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Pneumococcal vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Pneumococcal 10-valent vaccine conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Streptococcal infections; Tetanus
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms SPNG-003
  • Sponsors GlaxoSmithKline

Most Recent Events

  • 17 Jul 2017 Primary endpoint has been met. (Percentage of Subjects Reporting Fever 40 C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group), according to results published in the Vaccine.
  • 17 Jul 2017 Primary endpoint has been met. (Percentage of Subjects Reporting Fever 40.0C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group), according to results published in the Vaccine.
  • 17 Jul 2017 Results published in the Vaccine.

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