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

A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 23vPS

• Study Type: Interventional
• Enrollment (Actual): 938
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Arlov, Sweden, 23234
    • Pfizer Investigational Site
  • Boden, Sweden, 96131
    • Pfizer Investigational Site
  • Degeberga, Sweden, 29731
    • Pfizer Investigational Site
  • Gothenburg, Sweden, 40014
    • Pfizer Investigational Site
  • Malmoe, Sweden, 21120
    • Pfizer Investigational Site
  • Umea, Sweden, 90736
    • Pfizer Investigational Site
  • Uppsala, Sweden, 75185
    • Pfizer Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Pfizer Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Pfizer Investigational Site
    • Mesa, Arizona, United States, 85203
      • Pfizer Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80262
      • Pfizer Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Pfizer Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • Pfizer Investigational Site
    • Coral Gables, Florida, United States, 33134
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Pfizer Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33614
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30305
      • Pfizer Investigational Site
    • Stockbridge, Georgia, United States, 30328
      • Pfizer Investigational Site
  • Kansas
    • Shawnee Mission, Kansas, United States, 66128
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Pfizer Investigational Site
    • Rochester, Minnesota, United States, 55905
      • Pfizer Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63104
      • Pfizer Investigational Site
  • Montana
    • Butte, Montana, United States, 59701
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Pfizer Investigational Site
  • New York
    • Rochester, New York, United States, 14642
      • Pfizer Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Pfizer Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • Pfizer Investigational Site
    • Durham, North Carolina, United States, 27710
      • Pfizer Investigational Site
    • Durham, North Carolina, United States, 27705
      • Pfizer Investigational Site
    • Hickory, North Carolina, United States, 28601
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45236
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Pfizer Investigational Site
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • Pfizer Investigational Site
    • Downington, Pennsylvania, United States, 19335
      • Pfizer Investigational Site
    • Grove City, Pennsylvania, United States, 16127
      • Pfizer Investigational Site
    • Penndel, Pennsylvania, United States, 19047
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • Pfizer Investigational Site
    • Upper St. Clair, Pennsylvania, United States, 15241
      • Pfizer Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Pfizer Investigational Site
    • Mt. Pleasant, South Carolina, United States, 29464
      • Pfizer Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37232
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 998101
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Receives 13vPnC at year 0 and 13vPnC at year 1	Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
Active Comparator: 2; Receives 23vPS at year 0 and 13vPnC at year 1	Biological: 23vPS; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)	Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.	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)	Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 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, 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)	Antibody geometric mean titers as measured by 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, 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)	Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.	1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)	Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)	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)	Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)	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)	Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)	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 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )	Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)	Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)	Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)	Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).	Days 1 through 14 / Year 0
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).	Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).	Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).	Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).	Days 1 through 14 / Year 0, Days 1 through 14 / Year 1

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 18, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (Estimate): October 19, 2007

Study Record Updates

• Last Update Posted (Estimate): July 14, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6115A1-3005; B1851024