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

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

• Registration Number: NCT00427895
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-02-27
• Primary Completion: 2011-08-01
• Study Completion: 2011-08-01
• Results First Submitted: 2012-08-01
• Results First Submitted QC: 2012-08-01
• Results First Posted: 2012-09-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2141

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
13vPnC Cohort 3, Vaccination 1	13-valent pneumococcal conjugate vaccine (13vPnC)	Participants aged 18-49 years given a 0.5 mL dose administered on day 1.
23vPS Cohort 1, Vaccination 1	23-valent Pneumococcal Polysaccharide Vaccine (23vPS)	Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
23vPS Cohort 1, Vaccination 2	23-valent Pneumococcal Polysaccharide Vaccine (23vPS)	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.
13vPnC Cohort 2, Vaccination 2	13-valent pneumococcal conjugate vaccine (13vPnC)	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.
13vPnC Cohort 1, Vaccination 1	13-valent pneumococcal conjugate vaccine (13vPnC)	Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
13vPnC Cohort 2, Vaccination 1	13-valent pneumococcal conjugate vaccine (13vPnC)	Participants aged 50-59 years given a 0.5 mL dose administered on day 1.
13vPnC Cohort 1, Vaccination 2	13-valent pneumococcal conjugate vaccine (13vPnC)	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.

Primary Outcome Measures

Name	Time	Method
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	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4	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.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	One 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	One month after vaccination 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.

Secondary Outcome Measures

Name	Time	Method
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	Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4	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	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4	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.
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	One 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.

Trial Locations

Locations (21)

Kentucky Pediatric /Adult Research; 🇺🇸 Bardstown, Kentucky, United States

J. Lewis Research/First Med; 🇺🇸 West Jordan, Utah, United States

Heartland Research Associates, LLC; 🇺🇸 Wichita, Kansas, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

PMG Research of Raleigh, LLC; 🇺🇸 Raleigh, North Carolina, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Radiant Research - St. Louis; 🇺🇸 Saint Louis, Missouri, United States

J. Lewis Research Inc./Foothill Family Clinic South; 🇺🇸 Salt Lake City, Utah, United States

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States

Heartland Research Associates LLC; 🇺🇸 Wichita, Kansas, United States

East Valley Family Physicians, PLC; 🇺🇸 Chandler, Arizona, United States

Accelovance; 🇺🇸 South Bend, Indiana, United States

University Clinical Research, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Primary Physicians Research; 🇺🇸 Upper Saint Clair, Pennsylvania, United States

Clinical Research Advantage/Central Phoenix; 🇺🇸 Phoenix, Arizona, United States

Internal Medicine and Pediatrics Associates of Bristol, PC; 🇺🇸 Bristol, Tennessee, United States

PMG Research of Bristoll, LLC; 🇺🇸 Bristol, Tennessee, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Advanced Clinical Research; 🇺🇸 West Jordan, Utah, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States