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7-valent Pneumococcal Conjugated Vaccination (PCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00885625
Recruitment Status : Unknown
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 22, 2009
Last Update Posted : July 15, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.

Condition or disease Intervention/treatment Phase
Invasive Pneumococcal Disease Biological: 7-valent pneumococcal conjugated vaccine Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 1-Year Longitudinal Follow-up Study of Serologic Responses to 7-valent Pneumococcal Conjugated Vaccination and Opsonophagocytic Activities for Streptococcus Pneumoniae Among Patients With Human Immunodeficiency Virus Infection
Study Start Date : March 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: 7-valent pneumococcal conjugated vaccine
    7-valent pneumococcal conjugated vaccine is given twice with 4 weeks apart
    Other Name: Prevenar (Wyeth)

Outcome Measures

Primary Outcome Measures :
  1. 2-fold increase of antibody titers specific to pneumococcal serotypes [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. antibody titers specific to pneumococcal serotypes larger than 0.35ug/ml All-cause pneumonia [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected patients with age >18 years

Exclusion Criteria:

  • concurrent immunosuppressant use
  • Pregnant women
  • receipt of other vaccine within 3 months
  • active opportunistic infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885625


Contacts
Contact: Chien-Ching Hung, MD, MSc 886-2-23123456 ext 67552 hcc0401@ntu.edu.tw
Contact: Ching-Lan Lu, MD 886-2-23123456 ext 67552 syrupnicole@hotmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chien-Ching Hung, MD, MSc    886-2-23123456 ext 67552    hcc0401@ntu.edu.tw   
Contact: Ching-Lan Lu, MD    886-2-23123456 ext 67552    syrupnicole@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chien-Ching Hung, MD, MSc National Taiwan University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hung Chien-Ching, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00885625     History of Changes
Other Study ID Numbers: 200805005M
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: June 2010

Keywords provided by National Taiwan University Hospital:
invasive pneumococcal disease
pneumococcal conjugated vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Acquired Immunodeficiency Syndrome
HIV Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs