Clinical trial NCT02124161: Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Official title: A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Keywords: Pneumococcal polysaccharide vaccine
13-valent pneumococcal conjugate vaccine
invasive pneumococcal disease
flu vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 882
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.


Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
2. Male or female adults 50 years of age or older.
3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
4. Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion Criteria:

1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
2. History of severe adverse reactions associated with any vaccine or vaccine-related component.
3. Allergic to egg proteins (egg or egg products) and chicken proteins.
4. History of Guillain-Barré syndrome.
5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
6. Documented S pneumoniae infection within the past 5 years before investigational product administration.

Primary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes
timeFrame: 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC
measure: Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)
timeFrame: 1 month after Vaccination 1
measure: Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1
timeFrame: Within 28 to 42 days after Vaccination 1
measure: Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2
timeFrame: Within 28 to 42 days after Vaccination 2
measure: Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination
timeFrame: Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2
measure: Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up
timeFrame: Within 168 to 196 days after Vaccination 2
Secondary outcomes:
measure: Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
timeFrame: 1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC
measure: Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1
timeFrame: Immediately before Vaccination 1, 1 month after Vaccination 1
measure: Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2
timeFrame: Immediately before Vaccination 2, 1 month after Vaccination 2
measure: Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers
timeFrame: Immediately before Vaccination 1, 1 month after Vaccination 1
measure: Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1
timeFrame: Immediately before Vaccination 1, 1 month after Vaccination 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research (Formerly Accelovance)
state: Alabama
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanante South. Sacramento
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: Santa Clara
country: United States
facility: Kaiser Pemanente Santa Clara
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Mishawaka
country: United States
facility: Optimal Research, LLC
state: Indiana
city: Council Bluffs
country: United States
facility: Clinical Research Advantage, Inc/Ridge Family Practice
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc.
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Bellevue
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Carnegie
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: