Clinical Trial: Duration of Immunity Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3 Study To Assess The Persistence Of Hsba Response Up To 48 Months After Completion Of A Primary Series Of Bivalent Rlp2086, And The Safety, Tolerability, And Immunogenicity Of A Booster Dose

Brief Summary: This study is a follow-up of Pfizer studies using rLP (treatment assignment known) and investigational product (treatment assignment unknown) in which the subjects will attend up to 6 study visits for collection of a 20-mL blood sample at each visit.

Detailed Summary: Assess longevity of immune responses following receipt of 2 or 3 doses of bivalent rLP2086. The longevity of immune responses to concomitant vaccination
Sponsor: Pfizer

Current Primary Outcome:

  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 6 following last vaccination in primary study ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 12 following last vaccination in primary study ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 18 following last vaccination in primary study ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 24 following last vaccination in primary study ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 36 following last vaccination in primary study ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 48 following last vaccination in primary study ]


Original Primary Outcome:

  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 6 following last vaccination in primary study [ Time Frame: Month 6 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 12 following last vaccination in primary study [ Time Frame: Month 12 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 18 following last vaccination in primary study [ Time Frame: Month 18 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 24 following last vaccination in primary study [ Time Frame: Month 24 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 36 following last vaccination in primary study [ Time Frame: Month 36 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 48 following last vaccination in primary study [ Time Frame: Month 48 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 6 following last vaccination in primary study [ Time Frame: Month 6 following last vaccination in primary study ]
  • Percentage of Participants with

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Pfizer

    Dates:
    Date Received: February 17, 2012
    Date Started: September 2012
    Date Completion: January 2018
    Last Updated: May 5, 2017
    Last Verified: May 2017