Clinical trial NCT00427895: Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
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 Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Vaccine
Pneumococcal Infections Prevention and Control
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 2141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
timeFrame: One month after vaccination 1
measure: Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
timeFrame: One month after vaccination 1
measure: 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
timeFrame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Secondary outcomes:
measure: Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
timeFrame: One month after vaccination 1
measure: 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
timeFrame: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
measure: 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
timeFrame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Other outcomes:
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
timeFrame: Within 14 days after vaccination 2
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
timeFrame: Within 14 days after vaccination 2
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
timeFrame: Within 14 days after vaccination 1
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
timeFrame: Within 14 days after vaccination 1
Locations:
city: Huntsville
country: United States
facility: Accelovance
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians, PLC
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage/Central Phoenix
state: Arizona
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: South Bend
country: United States
facility: Accelovance
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric /Adult Research
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research - St. Louis
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Primary Physicians Research
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Primary Physicians Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Bristol
country: United States
facility: Internal Medicine and Pediatrics Associates of Bristol, PC
state: Tennessee
city: Bristol
country: United States
facility: PMG Research of Bristoll, LLC
state: Tennessee
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc./Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc./Foothill Family Clinic South
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: West Jordan
country: United States
facility: J. Lewis Research/First Med
state: Utah
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: