NCT00885625

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 15, 2010

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

April 20, 2009

Last Update Submit

July 14, 2010

Conditions

Invasive Pneumococcal Disease

Keywords

invasive pneumococcal diseasepneumococcal conjugated vaccine

Outcome Measures

Primary Outcomes (1)

  • 2-fold increase of antibody titers specific to pneumococcal serotypes

    48 weeks

Secondary Outcomes (1)

  • antibody titers specific to pneumococcal serotypes larger than 0.35ug/ml All-cause pneumonia

    48 weeks

Interventions

7-valent pneumococcal conjugated vaccineBIOLOGICAL

7-valent pneumococcal conjugated vaccine is given twice with 4 weeks apart

Also known as: Prevenar (Wyeth)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected patients with age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Lu CL, Chang SY, Chuang YC, Liu WC, Su CT, Su YC, Chang SF, Hung CC. Revaccination with 7-valent pneumococcal conjugate vaccine elicits better serologic response than 23-valent pneumococcal polysaccharide vaccine in HIV-infected adult patients who have undergone primary vaccination with 23-valent pneumococcal polysaccharide vaccine in the era of combination antiretroviral therapy. Vaccine. 2014 Feb 19;32(9):1031-5. doi: 10.1016/j.vaccine.2014.01.009. Epub 2014 Jan 15.

    PMID: 24440112DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Chien-Ching Hung, MD, MSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ching Hung, MD, MSc

CONTACT

886-2-23123456hcc0401@ntu.edu.tw

Ching-Lan Lu, MD

CONTACT

886-2-23123456syrupnicole@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-06

Locations

TW(1)