Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
2012. március 13. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
373
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Alaska
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Akiak, Alaska, Egyesült Államok, 99552
- Pfizer Investigational Site
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Bethel, Alaska, Egyesült Államok, 99559
- Pfizer Investigational Site
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Chefornak, Alaska, Egyesült Államok, 99561
- Pfizer Investigational Site
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Chevak, Alaska, Egyesült Államok, 99563
- Pfizer Investigational Site
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Eek, Alaska, Egyesült Államok, 99578
- Pfizer Investigational Site
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Emmonak, Alaska, Egyesült Államok, 99581
- Pfizer Investigational Site
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Hooper Bay, Alaska, Egyesült Államok, 99604
- Pfizer Investigational Site
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Kasigluk, Alaska, Egyesült Államok, 99609
- Pfizer Investigational Site
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Kongiganak, Alaska, Egyesült Államok, 99545
- Pfizer Investigational Site
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Kotlik, Alaska, Egyesült Államok, 99620
- Pfizer Investigational Site
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Kwethluk, Alaska, Egyesült Államok, 99621
- Pfizer Investigational Site
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Kwigillingok, Alaska, Egyesült Államok, 99622
- Pfizer Investigational Site
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Mtn. Village, Alaska, Egyesült Államok, 99632
- Pfizer Investigational Site
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Napaskiak, Alaska, Egyesült Államok, 99559
- Pfizer Investigational Site
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Newtok, Alaska, Egyesült Államok, 99559
- Pfizer Investigational Site
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Nunapitchuk, Alaska, Egyesült Államok, 99641
- Pfizer Investigational Site
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Russian Mission, Alaska, Egyesült Államok, 99657
- Pfizer Investigational Site
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Scammon Bay, Alaska, Egyesült Államok, 99662
- Pfizer Investigational Site
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Toksook Bay, Alaska, Egyesült Államok, 99637
- Pfizer Investigational Site
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Tuluksak, Alaska, Egyesült Államok, 99679
- Pfizer Investigational Site
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Upper Kalskag, Alaska, Egyesült Államok, 99607
- Pfizer Investigational Site
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
1 hónap (Gyermek)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Group1
Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
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4 doses of 13vPnC (0.5ml, IM) will be administered.
(3 doses infant series, and 1 toddler dose)
3 doses of 13vPnC (0.5ml, IM) will be administered.
(2 doses for infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(1 dose infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(2 catch-up dose(s) greater than 60 days apart )
1 dose of 13vPnC (0.5ml, IM) will be administered.
(1 catch-up dose)
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Kísérleti: Group 2
Subjects <12 months of age with 1 prior dose of Prevnar.
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4 doses of 13vPnC (0.5ml, IM) will be administered.
(3 doses infant series, and 1 toddler dose)
3 doses of 13vPnC (0.5ml, IM) will be administered.
(2 doses for infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(1 dose infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(2 catch-up dose(s) greater than 60 days apart )
1 dose of 13vPnC (0.5ml, IM) will be administered.
(1 catch-up dose)
|
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Kísérleti: Group 3
Subjects <12 months of age with 2 prior doses of Prevnar.
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4 doses of 13vPnC (0.5ml, IM) will be administered.
(3 doses infant series, and 1 toddler dose)
3 doses of 13vPnC (0.5ml, IM) will be administered.
(2 doses for infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(1 dose infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(2 catch-up dose(s) greater than 60 days apart )
1 dose of 13vPnC (0.5ml, IM) will be administered.
(1 catch-up dose)
|
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Kísérleti: Group 4
Subjects ≥12 months to <2 years of age.
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4 doses of 13vPnC (0.5ml, IM) will be administered.
(3 doses infant series, and 1 toddler dose)
3 doses of 13vPnC (0.5ml, IM) will be administered.
(2 doses for infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(1 dose infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(2 catch-up dose(s) greater than 60 days apart )
1 dose of 13vPnC (0.5ml, IM) will be administered.
(1 catch-up dose)
|
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Kísérleti: Group 5
Subjects ≥2 years to <5 years of age
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4 doses of 13vPnC (0.5ml, IM) will be administered.
(3 doses infant series, and 1 toddler dose)
3 doses of 13vPnC (0.5ml, IM) will be administered.
(2 doses for infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(1 dose infant series catch-up, and 1 toddler dose)
2 doses of 13vPnC (0.5ml, IM) will be administered.
(2 catch-up dose(s) greater than 60 days apart )
1 dose of 13vPnC (0.5ml, IM) will be administered.
(1 catch-up dose)
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
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
Időkeret: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
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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.
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28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
|
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Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
Időkeret: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
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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.
|
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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Időkeret: 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.
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28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Időkeret: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
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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.
|
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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
Időkeret: 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.
|
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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Időkeret: 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
Időkeret: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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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.
|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Időkeret: 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.
|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
Időkeret: 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
|
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Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
Időkeret: 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
Időkeret: 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
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
Időkeret: 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.
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Baseline to 6 months after last vaccination
|
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Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Időkeret: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
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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.
|
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GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Időkeret: 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
Időkeret: 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.
|
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Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Időkeret: 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.
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28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
|
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Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
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Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
Időkeret: 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.
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Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
Időkeret: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
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28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
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Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose
Időkeret: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
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28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
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Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
Időkeret: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
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
2009. január 1.
Elsődleges befejezés (Tényleges)
2010. szeptember 1.
A tanulmány befejezése (Tényleges)
2010. szeptember 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2008. augusztus 27.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2008. augusztus 28.
Első közzététel (Becslés)
2008. augusztus 29.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2012. március 15.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2012. március 13.
Utolsó ellenőrzés
2012. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 6096A1-3010
- B1851009
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. .