A Study to Evaluate the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)
Status: | Completed |
---|---|
Conditions: | Pneumonia, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 2/7/2015 |
Start Date: | August 2014 |
End Date: | July 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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™) are
superior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared
with participants administered Prevnar 13™ followed by placebo, and 2) GMTs to pneumococcal
serotypes shared by the two vaccines are non-inferior in participants administered Prevnar
13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™
followed by placebo.
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™) are
superior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared
with participants administered Prevnar 13™ followed by placebo, and 2) GMTs to pneumococcal
serotypes shared by the two vaccines are non-inferior in participants administered Prevnar
13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™
followed by placebo.
Inclusion Criteria:
- Any chronic illness must be documented to be in stable condition
- Male, or a female and agrees to remain abstinent or 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 weeks before
or during the current study
- Is breast-feeding
We found this trial at
18
sites
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