Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
13. marts 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
373
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Alaska
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Akiak, Alaska, Forenede Stater, 99552
- Pfizer Investigational Site
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Bethel, Alaska, Forenede Stater, 99559
- Pfizer Investigational Site
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Chefornak, Alaska, Forenede Stater, 99561
- Pfizer Investigational Site
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Chevak, Alaska, Forenede Stater, 99563
- Pfizer Investigational Site
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Eek, Alaska, Forenede Stater, 99578
- Pfizer Investigational Site
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Emmonak, Alaska, Forenede Stater, 99581
- Pfizer Investigational Site
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Hooper Bay, Alaska, Forenede Stater, 99604
- Pfizer Investigational Site
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Kasigluk, Alaska, Forenede Stater, 99609
- Pfizer Investigational Site
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Kongiganak, Alaska, Forenede Stater, 99545
- Pfizer Investigational Site
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Kotlik, Alaska, Forenede Stater, 99620
- Pfizer Investigational Site
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Kwethluk, Alaska, Forenede Stater, 99621
- Pfizer Investigational Site
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Kwigillingok, Alaska, Forenede Stater, 99622
- Pfizer Investigational Site
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Mtn. Village, Alaska, Forenede Stater, 99632
- Pfizer Investigational Site
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Napaskiak, Alaska, Forenede Stater, 99559
- Pfizer Investigational Site
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Newtok, Alaska, Forenede Stater, 99559
- Pfizer Investigational Site
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Nunapitchuk, Alaska, Forenede Stater, 99641
- Pfizer Investigational Site
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Russian Mission, Alaska, Forenede Stater, 99657
- Pfizer Investigational Site
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Scammon Bay, Alaska, Forenede Stater, 99662
- Pfizer Investigational Site
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Toksook Bay, Alaska, Forenede Stater, 99637
- Pfizer Investigational Site
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Tuluksak, Alaska, Forenede Stater, 99679
- Pfizer Investigational Site
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Upper Kalskag, Alaska, Forenede Stater, 99607
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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)
|
|
Eksperimentel: Group 2
Subjects <12 months of age with 1 prior dose of Prevnar.
|
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)
|
|
Eksperimentel: Group 3
Subjects <12 months of age with 2 prior doses of Prevnar.
|
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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Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
|
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Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2009
Primær færdiggørelse (Faktiske)
1. september 2010
Studieafslutning (Faktiske)
1. september 2010
Datoer for studieregistrering
Først indsendt
27. august 2008
Først indsendt, der opfyldte QC-kriterier
28. august 2008
Først opslået (Skøn)
29. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. marts 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. marts 2012
Sidst verificeret
1. marts 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6096A1-3010
- B1851009
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .