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Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

7 april 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

1116

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Chandler, Arizona, Förenta staterna, 85224
        • Clinical Research Advantage, Inc.
    • California
      • Rolling Hills Estates, California, Förenta staterna, 90274
        • Peninsula Research Associates
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045-7144
        • Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
    • Florida
      • Clearwater, Florida, Förenta staterna, 33761
        • Tampa Bay Medical Research, Inc.
      • Hialeah, Florida, Förenta staterna, 33012
        • A. G. A. Clinical Trials
    • Idaho
      • Meridian, Idaho, Förenta staterna, 83642
        • Advanced Clinical Research
    • Illinois
      • Peoria, Illinois, Förenta staterna, 61602
        • Accelovance
    • Maryland
      • Riverdale, Maryland, Förenta staterna, 20737
        • Suite 100
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Förenta staterna, 63141
        • Radiant Research, Inc
    • Montana
      • Butte, Montana, Förenta staterna, 59701
        • Big Sky Clinical Research
    • New York
      • Camillus, New York, Förenta staterna, 13031
        • FFM Clinical Research
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester Medical Center
      • Rochester, New York, Förenta staterna, 14609
        • Rochester Clinical Research
    • North Carolina
      • Cary, North Carolina, Förenta staterna, 27518
        • PMG Research of Raleigh, LLC
      • Hickory, North Carolina, Förenta staterna, 28601
        • PMG Research of Hickory, LLC
      • Hickory, North Carolina, Förenta staterna, 28601
        • Hickory Family Practice Associates
      • Hickory, North Carolina, Förenta staterna, 28602
        • PMG Research of Hickory, LLC
      • Hickory, North Carolina, Förenta staterna, 28601
        • Unifour Medical Research Associates
      • Hickory, North Carolina, Förenta staterna, 28602
        • Fairbrook Medical Clinic
      • Hickory, North Carolina, Förenta staterna, 28601
        • Unifour Medical Research Associates, LLC
      • Hickory, North Carolina, Förenta staterna, 28602
        • Unifour Medical Research Associates, LLC
      • Raleigh, North Carolina, Förenta staterna, 27609
        • PMG Research of Raleigh, LLC
      • Salisbury, North Carolina, Förenta staterna, 28144
        • PMG Research of Salisbury
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • PMG Research of Winston-Salem
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45206
        • Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
      • Cleveland, Ohio, Förenta staterna, 44122
        • Rapid Medical Research, Inc.
      • Franklin, Ohio, Förenta staterna, 45005
        • Prestige Clinical Research
    • Pennsylvania
      • Carnegie, Pennsylvania, Förenta staterna, 15106
        • Preferred Primary Care Physicians, Inc
      • Grove City, Pennsylvania, Förenta staterna, 16127
        • Family Healthcare Partners
      • Jefferson Hills, Pennsylvania, Förenta staterna, 15025
        • Family Practice Medical Associates South, Jefferson Office
      • Pittsburgh, Pennsylvania, Förenta staterna, 15241
        • Primary Physicians Research Inc.
      • Pittsburgh, Pennsylvania, Förenta staterna, 15217
        • Kid's Plus Pediatrics
      • Upper St. Clair, Pennsylvania, Förenta staterna, 15241
        • Family Practice Medical Associates South
      • Washington, Pennsylvania, Förenta staterna, 15301
        • The Washington Hospital Family Medicine
    • Tennessee
      • Bristol, Tennessee, Förenta staterna, 37620
        • PMG Research of Bristol, LLC
      • Bristol, Tennessee, Förenta staterna, 37620
        • Internal Medicine & Pediatric Associates of Bristol, PC
      • Knoxville, Tennessee, Förenta staterna, 37920
        • Volunteer Research Group
    • Texas
      • Houston, Texas, Förenta staterna, 77055-6040
        • Clark D. McKeever, M.D. Research for Health
      • San Antonio, Texas, Förenta staterna, 78229
        • Diagnostics Research Group
    • Utah
      • West Jordan, Utah, Förenta staterna, 84088
        • Advanced Clinical Research

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 59 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 1
arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
Biologisk: 13 valent pneumococcal conjugate vaccine
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Andra namn:
  • 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
Biologisk: 13 valent pneumococcal conjugate vaccine
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Andra namn:
  • 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle
Övrig: 2
arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
Biologisk: 13 valent pneumococcal conjugate vaccine
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Andra namn:
  • 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
Biologisk: 13 valent pneumococcal conjugate vaccine
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Andra namn:
  • 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Tidsram: 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.
1 month after Dose 1
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Tidsram: 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.
1 month after 13vPnC Dose at year 0

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
Tidsram: 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.
1 month after 13vPnC (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Tidsram: 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.
before 13vPnC (Year 5) 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 5)
Tidsram: 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)
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)
Tidsram: 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)
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)
Tidsram: 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)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
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)
Tidsram: 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.
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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)
Tidsram: 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)
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)
Tidsram: 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)
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Tidsram: 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)
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)
Tidsram: 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 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.
Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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)
Tidsram: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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.
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 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)
Tidsram: 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)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
Tidsram: Within 14 days after Dose 1 (Year 0)
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.
Within 14 days after Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
Tidsram: Within 14 days after Dose 2 (Year 0)
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.
Within 14 days after Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
Tidsram: Within 14 days after 13vPnC (Year 5)
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).
Within 14 days after 13vPnC (Year 5)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
Tidsram: Within 14 days after Dose 1 (Year 0)
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.
Within 14 days after Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
Tidsram: Within 14 days after Dose 2 (Year 0)
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.
Within 14 days after Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
Tidsram: Within 14 days after 13vPnC (Year 5)
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.
Within 14 days after 13vPnC (Year 5)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
Tidsram: Within 30 Minutes After Dose 1 (Year 0)
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.
Within 30 Minutes After Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
Tidsram: Within 30 Minutes After Dose 2 (Year 0)
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.
Within 30 Minutes After Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
Tidsram: Within 30 Minutes After 13vPnC (Year 5)
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).
Within 30 Minutes After 13vPnC (Year 5)
Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
Tidsram: Signing of informed consent up to 194 days after re-vaccination at Year 5
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.
Signing of informed consent up to 194 days after re-vaccination at Year 5

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2007

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 december 2013

Studieregistreringsdatum

Först inskickad

24 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2007

Första postat (Uppskatta)

28 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 april 2015

Senast verifierad

1 april 2015

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Andra studie-ID-nummer

  • 6115A1-3001
  • B1851020 (Annan identifierare: Alias Study Number)

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