Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00962780
First received: August 18, 2009
Last updated: May 8, 2013
Last verified: May 2013

August 18, 2009
May 8, 2013
March 2010
April 2013   (final data collection date for primary outcome measure)
  • Immune responses after 2 and 3 doses of 13vPnC as measured by serotype-specific immunoglobulin G (IgG) geometric mean fold rises (GMFRs) in all subjects. [ Time Frame: 1 month after 3 doses of 13vPnC (approx. 3 months) ] [ Designated as safety issue: No ]
  • Safety of 13vPnC measured by local reactions, systemic events. [ Time Frame: 14 days post-vaccination, doses 1- 3 ] [ Designated as safety issue: Yes ]
  • Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00962780 on ClinicalTrials.gov Archive Site
  • Immune responses after each dose of study vaccine as measured by IgG in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
  • Immune responses after each dose of study vaccine as measured by IgG in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
  • Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in all subjects. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
  • Immune responses after each dose of study vaccine as measured by opsonophagocytic activity in the pediatric & adult subgroups. [ Time Frame: 1 month post-vaccination, doses 1-4 ] [ Designated as safety issue: No ]
1.Immune responses after each dose of study vaccine as measured by IgG & opsonophagocytic activity in all subjects (except IgG GMFRs), & in the pediatric & adult subgroups. 2.Safety of 13vPnC measured by local reactions, systemic events & adverse events. [ Time Frame: Approx. 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Pneumococcal Infections
  • Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
    13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
    Other Name: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
    23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
    Other Name: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
  • Procedure: Blood draw
    Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
    Other Name: Blood draw
  • Procedure: Blood draw
    1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
    Other Name: Screening blood draw(s)
Experimental: 1
3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
Interventions:
  • Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
  • Procedure: Blood draw
  • Procedure: Blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
  • Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before study vaccination
  • Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
  • No previous vaccination with a pneumococcal vaccine
  • Subject or parent/legal guardian able to complete an electronic diary

Exclusion Criteria:

  • Acquired immune deficiency syndrome (AIDS) at time of enrollment
  • Current illicit substance and/or alcohol abuse
  • History of active chronic viral hepatitis
  • Previous anaphylactic reaction to a vaccine or vaccine-related component
  • Serious chronic disorders including metastatic malignancy and end-stage renal disease
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Romania
 
NCT00962780
6115A1-3002, B1851021
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP