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Trial record 3 of 10 for:    vaccine | Recruiting, Not yet recruiting Studies | United States, Utah | Adult | Studies that accept healthy volunteers

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

This study is currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT03313037
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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).

Condition Intervention Phase
Pneumococcal Infections Biological: Multivalent Biological: Prevnar 13 Biological: PPSV23 Other: Saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Adults 60 Through 64 Years Of Age

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness, swelling, and pain at the injection site). [ Time Frame: Day 10 ]
    Describe prompted local reactions after Vaccination 1.

  • Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events after Vaccination 1.

  • Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe adverse events occurring within 1 month after Vaccination 1.

  • Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months and 12 months after vaccination. [ Time Frame: Month 6 and Month 12 after Vaccination 1 ]
    Describe SAEs and NDCMCs occurring 6 months and 12 months after Vaccination 1.


Secondary Outcome Measures:
  • Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe OPA GMTs 1 month after vaccination.

  • Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before vaccination to 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe OPA GMFRs before vaccination to 1 month after vaccination.


Estimated Enrollment: 440
Actual Study Start Date: October 10, 2017
Estimated Study Completion Date: December 21, 2018
Estimated Primary Completion Date: December 21, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivalent
Pneumococcal conjugate vaccine
Biological: Multivalent
Pneumococcal conjugate vaccine
Other: Saline
Placebo
Active Comparator: Control
Prevnar 13 and PPSV23
Biological: Prevnar 13
Pneumococcal conjugate vaccine
Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
  2. 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.
  3. Female subjects who are not of childbearing potential.

Exclusion Criteria:

  1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.
  3. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313037


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Florida
QPS-MRA, LLC (Miami Research Associates) Not yet recruiting
South Miami, Florida, United States, 33143
United States, Kansas
Heartland Research Associates, LLC Not yet recruiting
Wichita, Kansas, United States, 67207
United States, Texas
Benchmark Research Recruiting
Austin, Texas, United States, 78705
United States, Utah
J. Lewis Research Inc. / Foothill Family Clinic Draper Recruiting
Draper, Utah, United States, 84020
J. Lewis Research, Inc. - Jordan River Family Medicine Recruiting
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03313037     History of Changes
Other Study ID Numbers: B7471002
First Submitted: October 9, 2017
First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs