Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
2015. április 7. frissítette: Pfizer
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
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
1116
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Arizona
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Chandler, Arizona, Egyesült Államok, 85224
- Clinical Research Advantage, Inc.
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California
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Rolling Hills Estates, California, Egyesült Államok, 90274
- Peninsula Research Associates
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Colorado
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Aurora, Colorado, Egyesült Államok, 80045-7144
- Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
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Florida
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Clearwater, Florida, Egyesült Államok, 33761
- Tampa Bay Medical Research, Inc.
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Hialeah, Florida, Egyesült Államok, 33012
- A. G. A. Clinical Trials
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Idaho
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Meridian, Idaho, Egyesült Államok, 83642
- Advanced Clinical Research
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Illinois
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Peoria, Illinois, Egyesült Államok, 61602
- Accelovance
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Maryland
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Riverdale, Maryland, Egyesült Államok, 20737
- Suite 100
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Minnesota
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Rochester, Minnesota, Egyesült Államok, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, Egyesült Államok, 63141
- Radiant Research, Inc
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Montana
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Butte, Montana, Egyesült Államok, 59701
- Big Sky Clinical Research
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New York
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Camillus, New York, Egyesült Államok, 13031
- FFM Clinical Research
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Rochester, New York, Egyesült Államok, 14642
- University of Rochester Medical Center
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Rochester, New York, Egyesült Államok, 14609
- Rochester Clinical Research
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North Carolina
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Cary, North Carolina, Egyesült Államok, 27518
- PMG Research of Raleigh, LLC
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Hickory, North Carolina, Egyesült Államok, 28601
- PMG Research of Hickory, LLC
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Hickory, North Carolina, Egyesült Államok, 28601
- Hickory Family Practice Associates
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Hickory, North Carolina, Egyesült Államok, 28602
- PMG Research of Hickory, LLC
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Hickory, North Carolina, Egyesült Államok, 28601
- Unifour Medical Research Associates
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Hickory, North Carolina, Egyesült Államok, 28602
- Fairbrook Medical Clinic
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Hickory, North Carolina, Egyesült Államok, 28601
- Unifour Medical Research Associates, LLC
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Hickory, North Carolina, Egyesült Államok, 28602
- Unifour Medical Research Associates, LLC
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Raleigh, North Carolina, Egyesült Államok, 27609
- PMG Research of Raleigh, LLC
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Salisbury, North Carolina, Egyesült Államok, 28144
- PMG Research of Salisbury
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Winston-Salem, North Carolina, Egyesült Államok, 27103
- PMG Research of Winston-Salem
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Ohio
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Cincinnati, Ohio, Egyesült Államok, 45206
- Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
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Cleveland, Ohio, Egyesült Államok, 44122
- Rapid Medical Research, Inc.
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Franklin, Ohio, Egyesült Államok, 45005
- Prestige Clinical Research
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Pennsylvania
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Carnegie, Pennsylvania, Egyesült Államok, 15106
- Preferred Primary Care Physicians, Inc
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Grove City, Pennsylvania, Egyesült Államok, 16127
- Family Healthcare Partners
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Jefferson Hills, Pennsylvania, Egyesült Államok, 15025
- Family Practice Medical Associates South, Jefferson Office
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Pittsburgh, Pennsylvania, Egyesült Államok, 15241
- Primary Physicians Research Inc.
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Pittsburgh, Pennsylvania, Egyesült Államok, 15217
- Kid's Plus Pediatrics
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Upper St. Clair, Pennsylvania, Egyesült Államok, 15241
- Family Practice Medical Associates South
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Washington, Pennsylvania, Egyesült Államok, 15301
- The Washington Hospital Family Medicine
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Tennessee
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Bristol, Tennessee, Egyesült Államok, 37620
- PMG Research of Bristol, LLC
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Bristol, Tennessee, Egyesült Államok, 37620
- Internal Medicine & Pediatric Associates of Bristol, PC
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Knoxville, Tennessee, Egyesült Államok, 37920
- Volunteer Research Group
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Texas
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Houston, Texas, Egyesült Államok, 77055-6040
- Clark D. McKeever, M.D. Research for Health
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San Antonio, Texas, Egyesült Államok, 78229
- Diagnostics Research Group
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Utah
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West Jordan, Utah, Egyesült Államok, 84088
- Advanced Clinical Research
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
50 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Egyéb: 1
arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
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TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Más nevek:
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Más nevek:
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Egyéb: 2
arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
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TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Más nevek:
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Időkeret: 1 month after Dose 1
|
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated.
N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen.
n=participants who met the prespecified level for the given antigen.
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1 month after Dose 1
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Időkeret: 1 month after 13vPnC Dose at year 0
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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1 month after 13vPnC Dose at year 0
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
Időkeret: 1 month after 13vPnC (Year 5)
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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1 month after 13vPnC (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Időkeret: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants with immunogenicity data at both Year 5 endpoints.
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before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
|
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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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)
Időkeret: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants
with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
|
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
|
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Időkeret: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
|
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
|
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)
Időkeret: before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
|
before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
|
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)
Időkeret: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data 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) blood draws.
CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
n=participants with valid and determinate assay results for the specified serotype at 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) blood draws.
|
Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
|
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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)
Időkeret: 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)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 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) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both the baseline and the various time points.
|
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)
|
|
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)
Időkeret: 1 month after 13vPnC (Year 5)
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
|
1 month after 13vPnC (Year 5)
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Időkeret: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both Year 5 time points.
|
before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points
|
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
|
|
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Időkeret: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
|
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
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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)
Időkeret: Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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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)
Időkeret: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV).
Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
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Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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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)
Időkeret: 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)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 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) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both the baseline and the various time points.
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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)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
Időkeret: Within 14 days after Dose 1 (Year 0)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 14 days after Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
Időkeret: Within 14 days after Dose 2 (Year 0)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 14 days after Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
Időkeret: Within 14 days after 13vPnC (Year 5)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
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Within 14 days after 13vPnC (Year 5)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
Időkeret: Within 14 days after Dose 1 (Year 0)
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Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
Időkeret: Within 14 days after Dose 2 (Year 0)
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Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
Időkeret: Within 14 days after 13vPnC (Year 5)
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Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after 13vPnC (Year 5)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
Időkeret: Within 30 Minutes After Dose 1 (Year 0)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 30 Minutes After Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
Időkeret: Within 30 Minutes After Dose 2 (Year 0)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 30 Minutes After Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
Időkeret: Within 30 Minutes After 13vPnC (Year 5)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
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Within 30 Minutes After 13vPnC (Year 5)
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Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
Időkeret: Signing of informed consent up to 194 days after re-vaccination at Year 5
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Non-serious AEs are AEs excluding SAEs.
In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.
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Signing of informed consent up to 194 days after re-vaccination at Year 5
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2007. szeptember 1.
Elsődleges befejezés (Tényleges)
2013. december 1.
A tanulmány befejezése (Tényleges)
2013. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2007. augusztus 24.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2007. augusztus 27.
Első közzététel (Becslés)
2007. augusztus 28.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. április 9.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. április 7.
Utolsó ellenőrzés
2015. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 6115A1-3001
- B1851020 (Egyéb azonosító: Alias Study Number)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .