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Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

NCT ID: NCT00427895

Last Updated: 2021-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-27

Study Completion Date

2011-08-01

Brief Summary

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This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Detailed Description

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Conditions

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Pneumococcal Infections

Keywords

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Vaccine Pneumococcal Infections Prevention and Control

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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13vPnC Cohort 1, Vaccination 1

Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL dose administered on day 1

23vPS Cohort 1, Vaccination 1

Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.

Group Type ACTIVE_COMPARATOR

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Intervention Type BIOLOGICAL

0.5 mL dose administered on day 1

13vPnC Cohort 2, Vaccination 1

Participants aged 50-59 years given a 0.5 mL dose administered on day 1.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL dose administered on day 1

13vPnC Cohort 3, Vaccination 1

Participants aged 18-49 years given a 0.5 mL dose administered on day 1.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL dose administered on day 1

13vPnC Cohort 1, Vaccination 2

Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL dose administered 3-4 years after dose 1

23vPS Cohort 1, Vaccination 2

Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.

Group Type ACTIVE_COMPARATOR

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Intervention Type BIOLOGICAL

0.5 mL dose administered 3-4 years after dose 1

13vPnC Cohort 2, Vaccination 2

Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL dose administered 3-4 years after dose 1

Interventions

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13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

Intervention Type BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

0.5 mL dose administered on day 1

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered 3-4 years after dose 1

Intervention Type BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

0.5 mL dose administered 3-4 years after dose 1

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered 3-4 years after dose 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
* Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
* Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion Criteria

* Previous immunization with any licensed or experimental pneumococcal vaccine.
* Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
* Known or suspected impairment of immunological function.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Accelovance

Huntsville, Alabama, United States

Site Status

East Valley Family Physicians, PLC

Chandler, Arizona, United States

Site Status

Clinical Research Advantage/Central Phoenix

Phoenix, Arizona, United States

Site Status

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

Site Status

Advanced Clinical Research

Meridian, Idaho, United States

Site Status

Accelovance

South Bend, Indiana, United States

Site Status

Heartland Research Associates LLC

Wichita, Kansas, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Kentucky Pediatric /Adult Research

Bardstown, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Radiant Research - St. Louis

St Louis, Missouri, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

PMG Research of Raleigh, LLC

Cary, North Carolina, United States

Site Status

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Primary Physicians Research

Pittsburgh, Pennsylvania, United States

Site Status

Primary Physicians Research

Upper Saint Clair, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Internal Medicine and Pediatrics Associates of Bristol, PC

Bristol, Tennessee, United States

Site Status

PMG Research of Bristoll, LLC

Bristol, Tennessee, United States

Site Status

J. Lewis Research Inc./Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

J. Lewis Research Inc./Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

J. Lewis Research/First Med

West Jordan, Utah, United States

Site Status

Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-004&StudyName=Study%20Comparing%20a%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20With%2023-valent%20Pneumococcal%20Polysaccharide%20Vaccine%20in%20Adults

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1851019

Identifier Type: OTHER

Identifier Source: secondary_id

6115A1-004

Identifier Type: -

Identifier Source: org_study_id

NCT00488852

Identifier Type: -

Identifier Source: nct_alias

NCT00774410

Identifier Type: -

Identifier Source: nct_alias