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Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

13. März 2012 aktualisiert von: Pfizer

A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

373

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alaska
      • Akiak, Alaska, Vereinigte Staaten, 99552
        • Pfizer Investigational Site
      • Bethel, Alaska, Vereinigte Staaten, 99559
        • Pfizer Investigational Site
      • Chefornak, Alaska, Vereinigte Staaten, 99561
        • Pfizer Investigational Site
      • Chevak, Alaska, Vereinigte Staaten, 99563
        • Pfizer Investigational Site
      • Eek, Alaska, Vereinigte Staaten, 99578
        • Pfizer Investigational Site
      • Emmonak, Alaska, Vereinigte Staaten, 99581
        • Pfizer Investigational Site
      • Hooper Bay, Alaska, Vereinigte Staaten, 99604
        • Pfizer Investigational Site
      • Kasigluk, Alaska, Vereinigte Staaten, 99609
        • Pfizer Investigational Site
      • Kongiganak, Alaska, Vereinigte Staaten, 99545
        • Pfizer Investigational Site
      • Kotlik, Alaska, Vereinigte Staaten, 99620
        • Pfizer Investigational Site
      • Kwethluk, Alaska, Vereinigte Staaten, 99621
        • Pfizer Investigational Site
      • Kwigillingok, Alaska, Vereinigte Staaten, 99622
        • Pfizer Investigational Site
      • Mtn. Village, Alaska, Vereinigte Staaten, 99632
        • Pfizer Investigational Site
      • Napaskiak, Alaska, Vereinigte Staaten, 99559
        • Pfizer Investigational Site
      • Newtok, Alaska, Vereinigte Staaten, 99559
        • Pfizer Investigational Site
      • Nunapitchuk, Alaska, Vereinigte Staaten, 99641
        • Pfizer Investigational Site
      • Russian Mission, Alaska, Vereinigte Staaten, 99657
        • Pfizer Investigational Site
      • Scammon Bay, Alaska, Vereinigte Staaten, 99662
        • Pfizer Investigational Site
      • Toksook Bay, Alaska, Vereinigte Staaten, 99637
        • Pfizer Investigational Site
      • Tuluksak, Alaska, Vereinigte Staaten, 99679
        • Pfizer Investigational Site
      • Upper Kalskag, Alaska, Vereinigte Staaten, 99607
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Monat bis 5 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
  • Infants who have received Prevnar are eligible to participate, but this is not required.
  • Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

  • Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group1
Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Experimental: Group 2
Subjects <12 months of age with 1 prior dose of Prevnar.
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Experimental: Group 3
Subjects <12 months of age with 2 prior doses of Prevnar.
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Experimental: Group 4
Subjects ≥12 months to <2 years of age.
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Experimental: Group 5
Subjects ≥2 years to <5 years of age
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Biologisch: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Zeitfenster: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Zeitfenster: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Zeitfenster: Day 1 through Day 7 after vaccination 2 for Group 4
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Day 1 through Day 7 after vaccination 2 for Group 4
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Zeitfenster: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Zeitfenster: Day 1 through Day 7 after vaccination 2 for Group 4
Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.
Day 1 through Day 7 after vaccination 2 for Group 4

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
Zeitfenster: Baseline to 6 months after last vaccination
In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC's AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.
Baseline to 6 months after last vaccination
Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
Zeitfenster: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose
Zeitfenster: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
Zeitfenster: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.

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Publikationen und hilfreiche Links

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Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2009

Primärer Abschluss (Tatsächlich)

1. September 2010

Studienabschluss (Tatsächlich)

1. September 2010

Studienanmeldedaten

Zuerst eingereicht

27. August 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. August 2008

Zuerst gepostet (Schätzen)

29. August 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. März 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. März 2012

Zuletzt verifiziert

1. März 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 6096A1-3010
  • B1851009

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