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7-valent Pneumococcal Conjugated Vaccination (PCV)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital Identifier:
First received: April 20, 2009
Last updated: July 14, 2010
Last verified: June 2010
Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.

Condition Intervention Phase
Invasive Pneumococcal Disease
Biological: 7-valent pneumococcal conjugated vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

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

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

Estimated Enrollment: 350
Study Start Date: March 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 7-valent pneumococcal conjugated vaccine
    7-valent pneumococcal conjugated vaccine is given twice with 4 weeks apart
    Other Name: Prevenar (Wyeth)
  Show Detailed Description


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00885625

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: Chien-Ching Hung, MD, MSc National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hung Chien-Ching, National Taiwan University Hospital Identifier: NCT00885625     History of Changes
Other Study ID Numbers: 200805005M 
Study First Received: April 20, 2009
Last Updated: July 14, 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
Immunologic Factors
Physiological Effects of Drugs processed this record on February 20, 2017