Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

Completed · Phase 2 · Has a placebo group

Conditions studied: Pneumococcal Infections

In brief

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).

Key facts

Study ID

NCT03313037

Run by

Pfizer

People needed

444

Starts

2017-10-10

Expected to finish

2018-12-10

Last updated by the study team

2019-12-26

Who can join

Age: 60 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
• Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
• Female subjects who are not of childbearing potential.

You may not qualify if…

• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Medical Research South, LLC — Charleston, South Carolina, United States
• Benchmark Research — Austin, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Martin Diagnostic Clinic — Tomball, Texas, United States
• J. Lewis Research Inc. / Foothill Family Clinic Draper — Draper, Utah, United States
• J. Lewis Research, Inc. - Jordan River Family Medicine — South Jordan, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.