NCT00574548

Brief Summary

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 9, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

December 13, 2007

Results QC Date

February 1, 2011

Last Update Submit

July 18, 2011

Conditions

Pneumococcal Vaccines

Keywords

Vaccines, Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (2)

  • Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)

    Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

    1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

  • Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)

    Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

    1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Secondary Outcomes (2)

  • Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)

    1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

  • Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)

    1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Other Outcomes (11)

  • Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)

    1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS

    14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)

    14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

  • +8 more other outcomes

Study Arms (3)

Group 1.1

EXPERIMENTAL

Group 1.1 = 13vPnC then 13vPnC

Biological: 13 valent Pneumococcal Conjugate Vaccine

Group 1.2

EXPERIMENTAL

Group 1.2 = 13vPnC then 23vPS

Biological: 13 valent Pneumococcal Conjugate VaccineBiological: 23-valent Pneumococcal Polysaccharide Vaccine

Group 2

EXPERIMENTAL

Group 2 = 23vPS then 13vPnC

Biological: 13 valent Pneumococcal Conjugate VaccineBiological: 23-valent Pneumococcal Polysaccharide Vaccine

Interventions

13 valent Pneumococcal Conjugate VaccineBIOLOGICAL

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1

Group 1.1
23-valent Pneumococcal Polysaccharide VaccineBIOLOGICAL

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

Group 2

Eligibility Criteria

Age60 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female, aged 60 to 64 years.
  • Healthy.

You may not qualify if:

  • Previous vaccination with any licensed or experimental pneumococcal vaccine.
  • History of severe adverse reaction associated with a vaccine.
  • Immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Chandler, Arizona, 85224, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83704, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

Location

Related Publications (1)

  • Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.

    PMID: 24606865DERIVED

Related Links

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 22, 2011

Results First Posted

May 9, 2011

Record last verified: 2011-07

Locations

US(6)