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Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (PILOT)

2011. október 5. frissítette: Pfizer

Characterization of the Prevnar Infant Long-term Immune Response vs a Prevnar Naive Cohort

The purpose of this study is to assess the "late" immune response to further doses of pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the Prevnar naive cohort which received MnCC). The study will take place at a single study center. Study participants must have participated previously in a specific Wyeth Prevnar study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente (NCKP) health plan.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

75

Fázis

  • 2. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • California
      • Hayward, California, Egyesült Államok, 94545
        • Pfizer Investigational Site
      • San Jose, California, Egyesült Államok, 95119
        • Pfizer Investigational Site

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

8 év (Gyermek)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR
  • Fully vaccinated per-protocol subjects from the control arm of the same study that did not receive Prevnar after the close of Study D118-P8, or at any time following the study, AND
  • Still enrolled in NCKP health plan.
  • Subjects included in either group above must be in good health as determined by medical history, physical examination, and clinical judgment.

Exclusion Criteria:

  • Previous receipt of pneumococcal polysaccharide vaccine.
  • History of documented recurrent pneumococcal otitis media or any occurence of pneumonia within past 12 months
  • History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
  • Known or suspected disease or dysfunction of the immune system, including:
  • HIV infection
  • Malignancy
  • Receipt of immunosuppressive therapy
  • Sickle cell hemoglobinopathy
  • Concomitant vaccination during the study period.
  • Known hypersensitivity to any component of Prevnar.
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
  • Receipt of immune globulin within the past 3 months.
  • Positive pregnancy test for menarchal female subjects.
  • Females who are breastfeeding.
  • For control subjects, previous receipt of Prevnar at any time.

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: Alapvető tudomány
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 1
Subjects received Prevnar in study D118-P8
Biológiai: 13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Más nevek:
  • 13vPnC
Kísérleti: 2
Subjects received MnCC in study D118-P8
Biológiai: 13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Más nevek:
  • 13vPnC

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Időkeret: Day 28 (Visit 5)
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.
Day 28 (Visit 5)
Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Időkeret: Day 7 (Visit 4)
Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.
Day 7 (Visit 4)
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Időkeret: Day 28 (Visit 5)
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Day 28 (Visit 5)
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Időkeret: Day 7 (Visit 4)
Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Day 7 (Visit 4)
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
Időkeret: Day 28 (Visit 5)
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Day 28 (Visit 5)
Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
Időkeret: Day 7 (Visit 4)
Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.
Day 7 (Visit 4)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Időkeret: Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Időkeret: Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Időkeret: Baseline (Visit 1), Day 7 (Visit 4)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 7 (Visit 4)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Időkeret: Baseline (Visit 1), Day 7 (Visit 4)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 7 (Visit 4)
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Időkeret: Baseline (Visit 1), Day 28 (Visit 5)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Időkeret: Baseline (Visit 1), Day 28 (Visit 5)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 28 (Visit 5)
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Időkeret: Baseline (Visit 1), Day 7 (Visit 4)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 7 (Visit 4)
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Időkeret: Baseline (Visit 1), Day 7 (Visit 4)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Baseline (Visit 1), Day 7 (Visit 4)
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Időkeret: Day 28 (Visit 5)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Day 28 (Visit 5)
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Időkeret: Day 7 (Visit 4)
Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Day 7 (Visit 4)
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
Időkeret: Day 28 (Visit 5)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Day 28 (Visit 5)
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
Időkeret: Day 7 (Visit 4)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Day 7 (Visit 4)

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Időkeret: Baseline up to 4 days after vaccination on Day 1
Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (> 7.0 cm). Participants may be represented in >1 category.
Baseline up to 4 days after vaccination on Day 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Időkeret: Baseline up to 4 days after vaccination on Day 1
Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).
Baseline up to 4 days after vaccination on Day 1

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Pfizer

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

Hasznos linkek

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

2010. január 1.

Elsődleges befejezés (Tényleges)

2010. szeptember 1.

A tanulmány befejezése (Tényleges)

2010. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2009. január 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2009. január 16.

Első közzététel (Becslés)

2009. január 19.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2011. november 11.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2011. október 5.

Utolsó ellenőrzés

2011. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 6096A1-3016
  • B1851014

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. .

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