Study

Overview

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

Eligibility

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

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Clinical Study Reports

Synopsis V110-029

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results