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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00279734
Date of registration: 19/01/2006
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb
Public title: Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Scientific title: An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
Date of first enrolment: August 2004
Target sample size: 80
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00279734
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy Subjects

- Body Weight between 60 and 100 kg.

- Males and Females must be using adequate contraceptive methods during study and for
10 weeks after dose of study mediciation.

Exclusion Criteria:

- Females who are prgnant or breastfeeding

- History of autoimmune disorder, immunodeficiency, or infection within past 3 months.

- Active TB requiring treatment within the previous 3 years.

- Positive breast cancer screen, PPD test.

- Vaccination with tetanus or pneumococcal vaccine within 5 years.

- Vaccination with any live vaccine within 4 weeks.

- History of drug or alcohol abuse.

- Any significant allergy.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept + vaccines
Drug: Tetanus + pnemococcal vaccines alone
Primary Outcome(s)
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary Outcome(s)
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Secondary ID(s)
IM101-049
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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