Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

NCT00546572 | Completed Phase 3 Results

• 2 other identifiers: 6115A1-3005B1851024
• Study Type: interventional
• Target: 938
• Locations: 2 countries
• Sites: 58

Brief Summary

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (2)

• Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)

  Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

  1 month after Vax 1 / Year 0

• Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)

  OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.

  Baseline, 1 month after Vax 1 / Year 0

Secondary Outcomes (4)

• Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)

  1 month after Vax 1 / Year 0

• Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)

  1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1

• Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)

  1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1

• Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)

  1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1

Other Outcomes (10)

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)

  Days 1 through 14 / Year 0

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)

  Days 1 through 14 / Year 0, Days 1 through 14 / Year 1

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)

  Days 1 through 14 / Year 0, Days 1 through 14 / Year 1

Study Arms (2)

1

EXPERIMENTAL

Receives 13vPnC at year 0 and 13vPnC at year 1

Biological: 13 valent Pneumococcal Conjugate Vaccine

2

ACTIVE COMPARATOR

Receives 23vPS at year 0 and 13vPnC at year 1

Biological: 23vPS

Interventions

13 valent Pneumococcal Conjugate Vaccine BIOLOGICAL

0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1

1

23vPS BIOLOGICAL

0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1

2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or Female aged 70 years or older.
• Documented vaccination with 1 dose of 23vPS at least 5 years previous.
• Healthy.

You may not qualify if:

• Receipt of more than one dose of 23vPS prior to enrollment.
• History of severe adverse reaction to a vaccine.
• Immunodeficiency.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (58)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

Location

Pfizer Investigational Site

Mesa, Arizona, 85203, United States

Location

Pfizer Investigational Site

Mesa, Arizona, 85213, United States

Location

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33761, United States

Location

Pfizer Investigational Site

Coral Gables, Florida, 33134, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

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Pinellas Park, Florida, 33781, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33614, United States

Location

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Atlanta, Georgia, 30305, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30328, United States

Location

Pfizer Investigational Site

Stockbridge, Georgia, 30328, United States

Location

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Shawnee Mission, Kansas, 66128, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40536, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21209, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55417, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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St Louis, Missouri, 63104, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Butte, Montana, 59701, United States

Location

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Las Vegas, Nevada, 89146, United States

Location

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Rochester, New York, 14642, United States

Location

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Cary, North Carolina, 27511, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27705, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28601, United States

Location

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Raleigh, North Carolina, 27612, United States

Location

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Salisbury, North Carolina, 28144, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

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Fargo, North Dakota, 58103, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45236, United States

Location

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Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Corvallis, Oregon, 97330, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Carnegie, Pennsylvania, 15106, United States

Location

Pfizer Investigational Site

Downington, Pennsylvania, 19335, United States

Location

Pfizer Investigational Site

Grove City, Pennsylvania, 16127, United States

Location

Pfizer Investigational Site

Penndel, Pennsylvania, 19047, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Pfizer Investigational Site

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Pfizer Investigational Site

Greer, South Carolina, 29651, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23507, United States

Location

Pfizer Investigational Site

Seattle, Washington, 998101, United States

Location

Pfizer Investigational Site

Arlöv, 23234, Sweden

Location

Pfizer Investigational Site

Boden, 96131, Sweden

Location

Pfizer Investigational Site

Degeberga, 29731, Sweden

Location

Pfizer Investigational Site

Gothenburg, 40014, Sweden

Location

Pfizer Investigational Site

Malmo, 21120, Sweden

Location

Pfizer Investigational Site

Umeå, 90736, Sweden

Location

Pfizer Investigational Site

Uppsala, 75185, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 14, 2011
• Results First Posted: May 30, 2011

Record last verified: 2011-07

Locations

US (51); SE (7)