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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

• Study Type: Interventional
• Enrollment (Actual): 2141
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Accelovance
  • Arizona
    • Chandler, Arizona, United States, 85224
      • East Valley Family Physicians, PLC
    • Phoenix, Arizona, United States, 85020
      • Clinical Research Advantage/Central Phoenix
  • Florida
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research, Inc.
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Accelovance
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates LLC
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky pediatric /Adult Research
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63141
      • Radiant Research - St. Louis
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Cary, North Carolina, United States, 275188
      • PMG Research of Raleigh, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15205
      • Primary Physicians Research
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Primary Physicians Research
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37520
      • Internal Medicine and Pediatrics Associates of Bristol, PC
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristoll, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research Inc./Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Inc./Foothill Family Clinic South
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
    • West Jordan, Utah, United States, 84088
      • J. Lewis Research/First Med
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13vPnC Cohort 1, Vaccination 1; Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered on day 1; Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered 3-4 years after dose 1
Active Comparator: 23vPS Cohort 1, Vaccination 1; Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.	Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 0.5 mL dose administered on day 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 0.5 mL dose administered 3-4 years after dose 1
Experimental: 13vPnC Cohort 2, Vaccination 1; Participants aged 50-59 years given a 0.5 mL dose administered on day 1.	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered on day 1; Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered 3-4 years after dose 1
Experimental: 13vPnC Cohort 3, Vaccination 1; Participants aged 18-49 years given a 0.5 mL dose administered on day 1.	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered on day 1; Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered 3-4 years after dose 1
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered on day 1; Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered 3-4 years after dose 1
Active Comparator: 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.	Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 0.5 mL dose administered on day 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 0.5 mL dose administered 3-4 years after dose 1
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered on day 1; Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL dose administered 3-4 years after dose 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month after vaccination 1
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.	One month after vaccination 1
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.	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month after vaccination 1
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.	Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
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.	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	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).	Within 14 days after vaccination 2
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	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.	Within 14 days after vaccination 2
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	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).	Within 14 days after vaccination 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	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.	Within 14 days after vaccination 1

Collaborators and Investigators

• Sponsor: 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 (Actual): February 27, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 25, 2007
• First Submitted That Met QC Criteria: January 26, 2007
• First Posted (Estimate): January 29, 2007

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Vaccine; Pneumococcal Infections Prevention and Control
• 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; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6115A1-004; B1851019 (Other Identifier: Alias Study Number)