Clinical trial NCT00521586: Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Official title: A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-28
Enrollment: 1116
Sex: ALL
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 50 to 59 years
* Determined by medical history, physical examination and clinical judgement to be eligible for the study
* Able to complete electronic diary
* Available for the 5 year 9 month duration of the study

Exclusion Criteria:

* Previous vaccination with any licensed or experimental pneumococcal vaccine
* Allergic to egg proteins and chicken proteins
* History of Guillian-Barre syndrome
* Vaccination with TIV within 6 months before study start
* Vaccination with diphtheria-containing vaccine within 6 months of study start
* Serious chronic disorders including immunodeficiency or metastatic malignancy
* Known or suspected hypersensitivity to any vaccine or vaccine component

Primary outcomes:
measure: Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
timeFrame: 1 month after Dose 1
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
timeFrame: 1 month after 13vPnC Dose at year 0
Secondary outcomes:
Other outcomes:
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
timeFrame: 1 month after 13vPnC (Year 5)
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
timeFrame: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
timeFrame: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
timeFrame: before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
timeFrame: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
timeFrame: Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
measure: Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)
timeFrame: 1 month after 13vPnC (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
timeFrame: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
timeFrame: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
timeFrame: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
timeFrame: Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
timeFrame: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
timeFrame: Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
timeFrame: Within 14 days after Dose 1 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
timeFrame: Within 14 days after Dose 2 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
timeFrame: Within 14 days after 13vPnC (Year 5)
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
timeFrame: Within 14 days after Dose 1 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
timeFrame: Within 14 days after Dose 2 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
timeFrame: Within 14 days after 13vPnC (Year 5)
measure: Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
timeFrame: Within 30 Minutes After Dose 1 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
timeFrame: Within 30 Minutes After Dose 2 (Year 0)
measure: Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
timeFrame: Within 30 Minutes After 13vPnC (Year 5)
measure: Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
timeFrame: Signing of informed consent up to 194 days after re-vaccination at Year 5
Locations:
city: Chandler
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Aurora
country: United States
facility: Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
state: Colorado
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: A. G. A. Clinical Trials
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: Riverdale
country: United States
facility: Suite 100
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research, Inc
state: Missouri
city: Butte
country: United States
facility: Big Sky Clinical Research
state: Montana
city: Camillus
country: United States
facility: FFM Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
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: Hickory
country: United States
facility: Hickory Family Practice Associates
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates, LLC
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Hickory
country: United States
facility: Fairbrook Medical Clinic
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical 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: Grove City
country: United States
facility: Family Healthcare Partners
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Family Practice Medical Associates South, Jefferson Office
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Kid's Plus Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research Inc.
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: Family Practice Medical Associates South
state: Pennsylvania
city: Washington
country: United States
facility: The Washington Hospital Family Medicine
state: Pennsylvania
city: Bristol
country: United States
facility: Internal Medicine & Pediatric Associates of Bristol, PC
state: Tennessee
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Houston
country: United States
facility: Clark D. McKeever, M.D. Research for Health
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
citation: Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.