Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (PILOT)
5 oktober 2011 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
75
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Hayward, California, Verenigde Staten, 94545
- Pfizer Investigational Site
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San Jose, California, Verenigde Staten, 95119
- Pfizer Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
8 jaar tot 16 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Subjects received Prevnar in study D118-P8
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single injection, single dose, single site, 0.5 mL per dose.
Andere namen:
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Experimenteel: 2
Subjects received MnCC in study D118-P8
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single injection, single dose, single site, 0.5 mL per dose.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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)
Tijdsspanne: Day 28 (Visit 5)
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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.
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Day 28 (Visit 5)
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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)
Tijdsspanne: Day 7 (Visit 4)
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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.
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Day 7 (Visit 4)
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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)
Tijdsspanne: Day 28 (Visit 5)
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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.
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Day 28 (Visit 5)
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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)
Tijdsspanne: Day 7 (Visit 4)
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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.
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Day 7 (Visit 4)
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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)
Tijdsspanne: Day 28 (Visit 5)
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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.
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Day 28 (Visit 5)
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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)
Tijdsspanne: Day 7 (Visit 4)
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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.
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Day 7 (Visit 4)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Tijdsspanne: Baseline (Visit 1), Day 28 (Visit 5)
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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.
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Baseline (Visit 1), Day 28 (Visit 5)
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Tijdsspanne: 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.
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Baseline (Visit 1), Day 28 (Visit 5)
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Tijdsspanne: Baseline (Visit 1), Day 7 (Visit 4)
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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.
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Baseline (Visit 1), Day 7 (Visit 4)
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Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Tijdsspanne: Baseline (Visit 1), Day 7 (Visit 4)
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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.
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Baseline (Visit 1), Day 7 (Visit 4)
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Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Tijdsspanne: Baseline (Visit 1), Day 28 (Visit 5)
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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.
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Baseline (Visit 1), Day 28 (Visit 5)
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Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Tijdsspanne: Baseline (Visit 1), Day 28 (Visit 5)
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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.
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Baseline (Visit 1), Day 28 (Visit 5)
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Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Tijdsspanne: Baseline (Visit 1), Day 7 (Visit 4)
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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.
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Baseline (Visit 1), Day 7 (Visit 4)
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Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
Tijdsspanne: Baseline (Visit 1), Day 7 (Visit 4)
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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.
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Baseline (Visit 1), Day 7 (Visit 4)
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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)
Tijdsspanne: Day 28 (Visit 5)
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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.
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Day 28 (Visit 5)
|
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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)
Tijdsspanne: 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)
|
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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)
Tijdsspanne: 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)
Tijdsspanne: 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.
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Day 7 (Visit 4)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
Tijdsspanne: Baseline up to 4 days after vaccination on Day 1
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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.
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Baseline up to 4 days after vaccination on Day 1
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Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
Tijdsspanne: Baseline up to 4 days after vaccination on Day 1
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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).
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Baseline up to 4 days after vaccination on Day 1
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2010
Primaire voltooiing (Werkelijk)
1 september 2010
Studie voltooiing (Werkelijk)
1 september 2010
Studieregistratiedata
Eerst ingediend
16 januari 2009
Eerst ingediend dat voldeed aan de QC-criteria
16 januari 2009
Eerst geplaatst (Schatting)
19 januari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
11 november 2011
Laatste update ingediend die voldeed aan QC-criteria
5 oktober 2011
Laatst geverifieerd
1 oktober 2011
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 6096A1-3016
- B1851014
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .