Status:
COMPLETED
Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypo...
Eligibility Criteria
Inclusion
- Any chronic illness must be documented to be in stable condition
- Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential
Exclusion
- Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
- Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease
- Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease
- Received systemic corticosteroids (equivalent of \>=2 mg/kg total daily dose of prednisone or \>=20 mg/kg for persons weighing \>10 kg) for \>=14 consecutive days and has not completed treatment \<=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (\~5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted).
- Has a coagulation disorder contraindicating intramuscular vaccination
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease
- Received a blood transfusion or blood products, including immunoglobulins \<=6 months before receiving study vaccine, or is scheduled to receive them within 30 days
- Participated in another clinical study of an investigational product \<=2 months before or during the current study
- Is breast-feeding
Key Trial Info
Start Date :
August 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02225587
Start Date
August 28 2014
End Date
July 6 2015
Last Update
November 2 2021
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