7-valent Pneumococcal Conjugated Vaccination (PCV)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00885625
First received: April 20, 2009
Last updated: July 14, 2010
Last verified: June 2010
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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 Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- antibody titers specific to pneumococcal serotypes larger than 0.35ug/ml All-cause pneumonia [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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)
![](https://webarchive.library.unt.edu/web/20130312223917im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
![](https://webarchive.library.unt.edu/web/20130312223917im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
![](https://webarchive.library.unt.edu/web/20130312223917im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
![](https://webarchive.library.unt.edu/web/20130312223917im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Hung Chien-Ching, National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00885625 History of Changes |
Other Study ID Numbers: | 200805005M |
Study First Received: | April 20, 2009 |
Last Updated: | July 14, 2010 |
Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
invasive pneumococcal disease pneumococcal conjugated vaccine |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV 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 |
ClinicalTrials.gov processed this record on March 10, 2013