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Protocol Summary for 107706

Protocol Summary
Protocol Id: 107706
Secondary Ids:
Title: To assess safety, reactogenicity & immunogenicity of a booster dose of pneumococcal conjugate vaccine, co-admin with GSK Biologicals’ MMRV vaccine in children (2nd yr of life) primed with the pneumococcal conjugate vaccine in study 105553.
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Finland: National Agency for Medicines
Collaborators:
Brief Summary:
Detailed Description:
Record Verification Date: July 2010
Status: Completed
Why Study Stopped:
Study Start Date: October 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: prevention
Allocation: Randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Post vacc: rectal fever >39°C
Secondary Outcomes:
  • AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens.
Conditions:
  • Pneumococcal Disease
Keywords:
  • Streptococcus pneumonia, pneumococcal conjugate vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Months
Maximum Age: 14 Months
Enrollment: 390
Enrollment Type:
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.