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A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

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ClinicalTrials.gov Identifier: NCT03313050
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 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 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Multivalent Biological: Tdap Biological: polysaccharide Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Observer-blinded
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50 Through 85 Years Of Age
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : May 24, 2019
Estimated Study Completion Date : May 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stage 1 multivalent (ages 50-64 years)
multivalent
Biological: Multivalent
Pneumococcal conjugate vaccine

Active Comparator: Stage 1 Tdap (ages 50-64 years)
Tdap
Biological: Tdap
Tetanus, diphtheria, acellular pertussis vaccine

Experimental: Stage 2 multivalent (ages 65-85 years)
multivalent
Biological: Multivalent
Pneumococcal conjugate vaccine

Active Comparator: Stage 2 polysaccharide (ages 65-85 years)
polysaccharide
Biological: polysaccharide
23-valent pneumococcal polysaccharide vaccine




Primary Outcome Measures :
  1. Percentage of subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at injection site) in each age group [ Time Frame: 14 days after vaccination ]
    Describe prompted local reactions after vaccination.

  2. Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each age group [ Time Frame: 14 days after vaccination ]
    Describe prompted systemic events after vaccination.

  3. Percentage of subjects reporting adverse events within 1 month after vaccination in each age group [ Time Frame: 1 month after vaccination ]
    Describe adverse events after vaccination.

  4. Percentage of subjects reporting serious adverse events and newly diagnosed chronic medical conditions within 6 months (both Stage 1 and Stage 2) [ Time Frame: 6 months after vaccination ]
    Describe SAEs and NDCMCs after vaccination.

  5. Percentage of subjects reporting serious adverse events and newly diagnosed chronic medical conditions within 12months (Stage 2 only) [ Time Frame: 12 months after vaccination ]
    Describe SAEs and NDCMCs after vaccination.


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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
  • Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion Criteria:

  • Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
  • Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13

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): NCT03313050


Locations
United States, Alabama
Achieve Clinical Research LLC
Birmingham, Alabama, United States, 35216
United States, California
Core Healthcare Group
Cerritos, California, United States, 90703
United States, Georgia
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
United States, Kansas
Augusta Family Practice
Augusta, Kansas, United States, 67010
Heartland Research Associates, LLC
Augusta, Kansas, United States, 67010
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, Nebraska
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research LLC
Omaha, Nebraska, United States, 68134
United States, North Carolina
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States, 28209
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Medical Research South, LLC
Charleston, South Carolina, United States, 29407
United States, Utah
J. Lewis Research Incorporated, Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03313050     History of Changes
Other Study ID Numbers: C3571001
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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