Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) - Full Text View

Purpose

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: 13 valent Pneumococcal Conjugate Vaccine Biological: 23vPS	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	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 (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment

Resource links provided by NLM:

MedlinePlus related topics: Pneumococcal Infections

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0 ] [ Designated as safety issue: No ]
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common 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.
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: Baseline, 1 month after Vax 1 / Year 0 ] [ Designated as safety issue: No ]
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.

Secondary Outcome Measures:

Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0 ] [ Designated as safety issue: Yes ]
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ] [ Designated as safety issue: No ]
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 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.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ] [ Designated as safety issue: No ]
Antibody geometric mean titers as measured by OPA assays for the 12 common 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.
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ] [ Designated as safety issue: No ]
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.

Enrollment:	938
Study Start Date:	November 2007
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Receives 13vPnC at year 0 and 13vPnC at year 1	Biological: 13 valent Pneumococcal Conjugate Vaccine 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
Active Comparator: 2 Receives 23vPS at year 0 and 13vPnC at year 1	Biological: 23vPS 0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or Female aged 70 years or older.
Documented vaccination with 1 dose of 23vPS at least 5 years previous.
Healthy.

Exclusion Criteria:

Receipt of more than one dose of 23vPS prior to enrollment.
History of severe adverse reaction to a vaccine.
Immunodeficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546572

Show 58 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00546572 History of Changes
Other Study ID Numbers:	6115A1-3005, B1851024
Study First Received:	October 18, 2007
Results First Received:	April 29, 2011
Last Updated:	July 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013