Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated

NCT01025336 | Completed Phase 3 Results

• 2 other identifiers: 6115A1-3018B1851029
• Study Type: interventional
• Target: 962
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).

Conditions

Healthy

Keywords

Antibody persistence

Outcome Measures

Primary Outcomes (2)

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)

  Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.

  Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)

  Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.

  Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

Secondary Outcomes (19)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)

  Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

  Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)

  Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

  Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)

• Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)

  Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)

Study Arms (2)

23vPS Naive

OTHER

Group 1.1 13vPnC/13vPnC Group 1.2 13vPnC/23vPS Group 2 23vPS/13vPNC

Other: Blood draw

Prior 23vPS>/= 5 years

OTHER

Group 1 13vPnC/13vPnC Group 2 23vPS/13vPnC

Other: Blood draw

Interventions

Blood draw OTHER

Group 1.1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1 Group 1.2- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1

23vPS Naive

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only study volunteers who received both assigned vaccinations at visit 1 and visit 4 when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572)

You may not qualify if:

• Vaccination with any licensed or experimental pneumococcal vaccine since being enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other than study vaccines permitted in 6115A1-3010 or 6115A1-3005)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Pfizer Investigational Site

Chandler, Arizona, 85224, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85258, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Pinellas Park, Florida, 33781, United States

Location

Pfizer Investigational Site

Meridian, Idaho, 83642, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40536, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64114, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63104, United States

Location

Pfizer Investigational Site

Rochester, New York, 14642-8410, United States

Location

Pfizer Investigational Site

Cary, North Carolina, 27518, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27704, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44122, United States

Location

Pfizer Investigational Site

Corvallis, Oregon, 97330, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Carnegie, Pennsylvania, 15106, United States

Location

Pfizer Investigational Site

Grove City, Pennsylvania, 16127, United States

Location

Pfizer Investigational Site

Jefferson, Pennsylvania, 15025, United States

Location

Pfizer Investigational Site

Penndel, Pennsylvania, 63117, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Pfizer Investigational Site

Greer, South Carolina, 29651, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-2581, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Schmoele-Thoma B, van Cleeff M, Greenberg RN, Gurtman A, Jones TR, Sundaraiyer V, Gruber WC, Scott DA. Persistence of antibodies 1 year after sequential administration of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine in adults. Hum Vaccin Immunother. 2019;15(3):575-583. doi: 10.1080/21645515.2018.1538618. Epub 2019 Jan 16.

  PMID: 30648932 DERIVED

Related Links

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 20, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-05

Locations

US (29)