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

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NCT00962780

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Study Location
Pfizer Investigational Site
Bucuresti, , 021105, Romania
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Pneumococcal Infections
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
    13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
    23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
  • 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).
  • 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)
Study Arms  ICMJE 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
Publications * Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015 Jul 17;29(11):1345-54. doi: 10.1097/QAD.0000000000000689.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2013)		303
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)		300
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962780
Other Study ID Numbers  ICMJE 6115A1-3002
B1851021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

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