Clinical Trial: Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults

Brief Summary: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.

Detailed Summary: This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Subjects With Any Solicited Local and General Symptoms [ Time Frame: During a 7-day follow up period after any vaccination ]

    Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.

    Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.

  • Number of Subjects With Any Unsolicited Adverse Events (AE) [ Time Frame: During a 30-day (Days 0-29) follow up period after any vaccination ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
  • Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 420 ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/inca

    Original Primary Outcome:

    • Occurrence of any solicited local and general adverse events [ Time Frame: During a 7-day follow up period after each vaccine dose ]
    • Occurrence of any unsolicited adverse events [ Time Frame: During a 30-day follow up period after each vaccine dose ]
    • Occurrence of any laboratory abnormalities [ Time Frame: During 7 days after each vaccine dose ]
    • Occurrence of any serious adverse events (SAE) [ Time Frame: From first vaccine dose to study conclusion ]


    Current Secondary Outcome:

    • Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) [ Time Frame: Days 0, 30, 60, 90, 180 and 420. ]
      Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.
    • Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. [ Time Frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. ]

      The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:

      Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17.

    • Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. [ Time Frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. ]

      The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:

      C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17).



    Original Secondary Outcome: Anti-NTHi and anti-pneumococcal candidate vaccine antigens [ Time Frame: Prior to and at 14 and 30 days after each vaccine dose ]

    Information By: GlaxoSmithKline

    Dates:
    Date Received: December 23, 2008
    Date Started: January 2009
    Date Completion:
    Last Updated: July 18, 2013
    Last Verified: July 2013