Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
13 de março de 2012 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Tipo de estudo
Intervencional
Inscrição (Real)
373
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alaska
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Akiak, Alaska, Estados Unidos, 99552
- Pfizer Investigational Site
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Bethel, Alaska, Estados Unidos, 99559
- Pfizer Investigational Site
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Chefornak, Alaska, Estados Unidos, 99561
- Pfizer Investigational Site
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Chevak, Alaska, Estados Unidos, 99563
- Pfizer Investigational Site
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Eek, Alaska, Estados Unidos, 99578
- Pfizer Investigational Site
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Emmonak, Alaska, Estados Unidos, 99581
- Pfizer Investigational Site
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Hooper Bay, Alaska, Estados Unidos, 99604
- Pfizer Investigational Site
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Kasigluk, Alaska, Estados Unidos, 99609
- Pfizer Investigational Site
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Kongiganak, Alaska, Estados Unidos, 99545
- Pfizer Investigational Site
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Kotlik, Alaska, Estados Unidos, 99620
- Pfizer Investigational Site
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Kwethluk, Alaska, Estados Unidos, 99621
- Pfizer Investigational Site
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Kwigillingok, Alaska, Estados Unidos, 99622
- Pfizer Investigational Site
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Mtn. Village, Alaska, Estados Unidos, 99632
- Pfizer Investigational Site
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Napaskiak, Alaska, Estados Unidos, 99559
- Pfizer Investigational Site
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Newtok, Alaska, Estados Unidos, 99559
- Pfizer Investigational Site
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Nunapitchuk, Alaska, Estados Unidos, 99641
- Pfizer Investigational Site
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Russian Mission, Alaska, Estados Unidos, 99657
- Pfizer Investigational Site
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Scammon Bay, Alaska, Estados Unidos, 99662
- Pfizer Investigational Site
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Toksook Bay, Alaska, Estados Unidos, 99637
- Pfizer Investigational Site
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Tuluksak, Alaska, Estados Unidos, 99679
- Pfizer Investigational Site
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Upper Kalskag, Alaska, Estados Unidos, 99607
- Pfizer Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
1 mês a 5 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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)
Prazo: 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
Prazo: 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.
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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 ≥1.0 Mcg/mL 1 Month After the Toddler Dose
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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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
Prazo: 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.
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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 Systemic Events: Catch-up Dose 2
Prazo: Day 1 through Day 7 after vaccination 2 for Group 4
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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.
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Day 1 through Day 7 after vaccination 2 for Group 4
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
Prazo: Baseline to 6 months after last vaccination
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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
Prazo: 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 ≥0.15 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 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 ≥0.15 Mcg/mL 1 Month After the Toddler Dose
Prazo: 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 ≥0.15 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
Prazo: 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.
|
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
Prazo: 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.
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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
Prazo: 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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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.
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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
Prazo: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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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.
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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 Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
Prazo: 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 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
Prazo: 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 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 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
Prazo: 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.
|
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Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
Prazo: 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 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.
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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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Pneumococcal OPA GMTs 1 Month After the Toddler Dose
Prazo: 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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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
Prazo: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
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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.
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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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Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2009
Conclusão Primária (Real)
1 de setembro de 2010
Conclusão do estudo (Real)
1 de setembro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
27 de agosto de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de agosto de 2008
Primeira postagem (Estimativa)
29 de agosto de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
15 de março de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de março de 2012
Última verificação
1 de março de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6096A1-3010
- B1851009
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .