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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)

ClinicalTrials.gov Identifier: NCT02225587 (view full study on clinicaltrials.gov)
Condition:  Pneumococcal infections
Status:  Completed


Official Title: Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Subjects 50 Years of Age and Older

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 hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.

Study Type:
Interventional
Study Phase:
Phase 3
Enrollment:
400
Study Start Date:
August 2014
Study Completion Date:
July 2015
Primary Completion Date:
July 2015
Ages Eligible for Study:
50 years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
Yes


CRITERIA

Inclusion Criteria:

  • 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 Criteria:

  • 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

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Clinical Study Reports

Synopsis  V110-029


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