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

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine (13vPnC)
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
13-valent pneumococcal conjugate vaccine (13vPnC)
13-valent pneumococcal conjugate vaccine (13vPnC)
13-valent pneumococcal conjugate vaccine (13vPnC)
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
13-valent pneumococcal conjugate vaccine (13vPnC)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Vaccine, Pneumococcal Infections Prevention and Control

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Accelovance
  • East Valley Family Physicians, PLC
  • Clinical Research Advantage/Central Phoenix
  • University Clinical Research, Inc.
  • Advanced Clinical Research
  • Accelovance
  • Heartland Research Associates LLC
  • Heartland Research Associates, LLC
  • Kentucky Pediatric /Adult Research
  • University of Louisville
  • Center for Pharmaceutical Research
  • Radiant Research - St. Louis
  • University of Rochester Medical Center
  • PMG Research of Raleigh, LLC
  • PMG Research of Raleigh, LLC
  • Cincinnati Children's Hospital Medical Center
  • Primary Physicians Research
  • Primary Physicians Research
  • Omega Medical Research
  • Internal Medicine and Pediatrics Associates of Bristol, PC
  • PMG Research of Bristoll, LLC
  • J. Lewis Research Inc./Foothill Family Clinic South
  • J. Lewis Research Inc./Foothill Family Clinic South
  • Advanced Clinical Research
  • J. Lewis Research/First Med
  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Experimental

Arm Label

13vPnC Cohort 1, Vaccination 1

23vPS Cohort 1, Vaccination 1

13vPnC Cohort 2, Vaccination 1

13vPnC Cohort 3, Vaccination 1

13vPnC Cohort 1, Vaccination 2

23vPS Cohort 1, Vaccination 2

13vPnC Cohort 2, Vaccination 2

Arm Description

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

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

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

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Secondary Outcome Measures

Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Full Information

First Posted
January 25, 2007
Last Updated
November 11, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00427895
Brief Title
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Official Title
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 Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2007 (Actual)
Primary Completion Date
August 1, 2011 (Actual)
Study Completion Date
August 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Vaccine, Pneumococcal Infections Prevention and Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13vPnC Cohort 1, Vaccination 1
Arm Type
Experimental
Arm Description
Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
Arm Title
23vPS Cohort 1, Vaccination 1
Arm Type
Active Comparator
Arm Description
Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
Arm Title
13vPnC Cohort 2, Vaccination 1
Arm Type
Experimental
Arm Description
Participants aged 50-59 years given a 0.5 mL dose administered on day 1.
Arm Title
13vPnC Cohort 3, Vaccination 1
Arm Type
Experimental
Arm Description
Participants aged 18-49 years given a 0.5 mL dose administered on day 1.
Arm Title
13vPnC Cohort 1, Vaccination 2
Arm Type
Experimental
Arm Description
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.
Arm Title
23vPS Cohort 1, Vaccination 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
13vPnC Cohort 2, Vaccination 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL dose administered on day 1
Intervention Type
Biological
Intervention Name(s)
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Intervention Description
0.5 mL dose administered on day 1
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL dose administered on day 1
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL dose administered on day 1
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL dose administered 3-4 years after dose 1
Intervention Type
Biological
Intervention Name(s)
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Intervention Description
0.5 mL dose administered 3-4 years after dose 1
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL dose administered 3-4 years after dose 1
Primary Outcome Measure Information:
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Description
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame
One month after vaccination 1
Title
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
Description
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time Frame
One month after vaccination 1
Title
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Description
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Description
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Time Frame
One month after vaccination 1
Title
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Description
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time Frame
Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
Title
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Description
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time Frame
One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Description
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Time Frame
Within 14 days after vaccination 2
Title
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Description
Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.
Time Frame
Within 14 days after vaccination 2
Title
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Description
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Time Frame
Within 14 days after vaccination 1
Title
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Description
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Time Frame
Within 14 days after vaccination 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Accelovance
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Research Advantage/Central Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Accelovance
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Pediatric /Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Radiant Research - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
275188
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Primary Physicians Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15205
Country
United States
Facility Name
Primary Physicians Research
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Internal Medicine and Pediatrics Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37520
Country
United States
Facility Name
PMG Research of Bristoll, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
J. Lewis Research Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
J. Lewis Research/First Med
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Links:
URL
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
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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