Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
13. března 2012 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
373
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alaska
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Akiak, Alaska, Spojené státy, 99552
- Pfizer Investigational Site
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Bethel, Alaska, Spojené státy, 99559
- Pfizer Investigational Site
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Chefornak, Alaska, Spojené státy, 99561
- Pfizer Investigational Site
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Chevak, Alaska, Spojené státy, 99563
- Pfizer Investigational Site
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Eek, Alaska, Spojené státy, 99578
- Pfizer Investigational Site
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Emmonak, Alaska, Spojené státy, 99581
- Pfizer Investigational Site
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Hooper Bay, Alaska, Spojené státy, 99604
- Pfizer Investigational Site
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Kasigluk, Alaska, Spojené státy, 99609
- Pfizer Investigational Site
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Kongiganak, Alaska, Spojené státy, 99545
- Pfizer Investigational Site
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Kotlik, Alaska, Spojené státy, 99620
- Pfizer Investigational Site
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Kwethluk, Alaska, Spojené státy, 99621
- Pfizer Investigational Site
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Kwigillingok, Alaska, Spojené státy, 99622
- Pfizer Investigational Site
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Mtn. Village, Alaska, Spojené státy, 99632
- Pfizer Investigational Site
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Napaskiak, Alaska, Spojené státy, 99559
- Pfizer Investigational Site
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Newtok, Alaska, Spojené státy, 99559
- Pfizer Investigational Site
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Nunapitchuk, Alaska, Spojené státy, 99641
- Pfizer Investigational Site
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Russian Mission, Alaska, Spojené státy, 99657
- Pfizer Investigational Site
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Scammon Bay, Alaska, Spojené státy, 99662
- Pfizer Investigational Site
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Toksook Bay, Alaska, Spojené státy, 99637
- Pfizer Investigational Site
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Tuluksak, Alaska, Spojené státy, 99679
- Pfizer Investigational Site
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Upper Kalskag, Alaska, Spojené státy, 99607
- Pfizer Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
1 měsíc až 5 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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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Experimentální: 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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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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
Časové okno: 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.
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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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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
Časové okno: 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 ≥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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: 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.
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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
Časové okno: 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 ≥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
Časové okno: 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 ≥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.
|
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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
Časové okno: 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.
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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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Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
Časové okno: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
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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.
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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
Časové okno: Day 1 through Day 7 after vaccination 2 for Group 4
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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
Časové okno: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
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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.
|
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Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
Časové okno: 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 ≥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.
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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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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
Časové okno: 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.
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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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GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
Časové okno: 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.
|
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GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2009
Primární dokončení (Aktuální)
1. září 2010
Dokončení studie (Aktuální)
1. září 2010
Termíny zápisu do studia
První předloženo
27. srpna 2008
První předloženo, které splnilo kritéria kontroly kvality
28. srpna 2008
První zveřejněno (Odhad)
29. srpna 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
15. března 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. března 2012
Naposledy ověřeno
1. března 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 6096A1-3010
- B1851009
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .