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

NCT00427895 | Completed Phase 3 Results

• 2 other identifiers: 6115A1-004B1851019
• Study Type: interventional
• Target: 2,141
• Locations: 1 country
• Sites: 26

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.

Conditions

Pneumococcal Infections

Keywords

Vaccine; Pneumococcal Infections Prevention and Control

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1

  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

  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

  One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Other Outcomes (4)

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2

  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

  Within 14 days after vaccination 2

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1

  Within 14 days after vaccination 1

Study Arms (7)

13vPnC Cohort 1, Vaccination 1

EXPERIMENTAL

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

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

23vPS Cohort 1, Vaccination 1

ACTIVE COMPARATOR

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

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

13vPnC Cohort 2, Vaccination 1

EXPERIMENTAL

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

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

13vPnC Cohort 3, Vaccination 1

EXPERIMENTAL

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

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

13vPnC Cohort 1, Vaccination 2

EXPERIMENTAL

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)

23vPS Cohort 1, Vaccination 2

ACTIVE COMPARATOR

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)

13vPnC Cohort 2, Vaccination 2

EXPERIMENTAL

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)

Interventions

13-valent pneumococcal conjugate vaccine (13vPnC) BIOLOGICAL

0.5 mL dose administered on day 1

13vPnC Cohort 1, Vaccination 1

23-valent Pneumococcal Polysaccharide Vaccine (23vPS) BIOLOGICAL

0.5 mL dose administered on day 1

23vPS Cohort 1, Vaccination 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (26)

Accelovance

Huntsville, Alabama, 35802, United States

Location

East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Clinical Research Advantage/Central Phoenix

Phoenix, Arizona, 85020, United States

Location

University Clinical Research, Inc.

Pembroke Pines, Florida, 33024, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Accelovance

South Bend, Indiana, 46601, United States

Location

Heartland Research Associates LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric /Adult Research

Bardstown, Kentucky, 40004, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Radiant Research - St. Louis

St Louis, Missouri, 63141, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

PMG Research of Raleigh, LLC

Cary, North Carolina, 275188, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Primary Physicians Research

Pittsburgh, Pennsylvania, 15205, United States

Location

Primary Physicians Research

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Internal Medicine and Pediatrics Associates of Bristol, PC

Bristol, Tennessee, 37520, United States

Location

PMG Research of Bristoll, LLC

Bristol, Tennessee, 37620, United States

Location

J. Lewis Research Inc./Foothill Family Clinic South

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research Inc./Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

J. Lewis Research/First Med

West Jordan, Utah, 84088, United States

Location

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: February 27, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 15, 2021
• Results First Posted: September 5, 2012

Record last verified: 2021-11

Locations

US (26)