Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
7 de abril de 2015 atualizado por: Pfizer
A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart.
It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1116
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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Arizona
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Chandler, Arizona, Estados Unidos, 85224
- Clinical Research Advantage, Inc.
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California
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Rolling Hills Estates, California, Estados Unidos, 90274
- Peninsula Research Associates
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-7144
- Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
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Florida
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Clearwater, Florida, Estados Unidos, 33761
- Tampa Bay Medical Research, Inc.
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Hialeah, Florida, Estados Unidos, 33012
- A. G. A. Clinical Trials
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Idaho
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Meridian, Idaho, Estados Unidos, 83642
- Advanced Clinical Research
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
- Accelovance
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Maryland
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Riverdale, Maryland, Estados Unidos, 20737
- Suite 100
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, Estados Unidos, 63141
- Radiant Research, Inc
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Montana
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Butte, Montana, Estados Unidos, 59701
- Big Sky Clinical Research
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New York
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Camillus, New York, Estados Unidos, 13031
- FFM Clinical Research
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research
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North Carolina
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Cary, North Carolina, Estados Unidos, 27518
- PMG Research of Raleigh, LLC
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Hickory, North Carolina, Estados Unidos, 28601
- PMG Research of Hickory, LLC
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Hickory, North Carolina, Estados Unidos, 28601
- Hickory Family Practice Associates
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Hickory, North Carolina, Estados Unidos, 28602
- PMG Research of Hickory, LLC
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Hickory, North Carolina, Estados Unidos, 28601
- Unifour Medical Research Associates
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Hickory, North Carolina, Estados Unidos, 28602
- Fairbrook Medical Clinic
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Hickory, North Carolina, Estados Unidos, 28601
- Unifour Medical Research Associates, LLC
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Hickory, North Carolina, Estados Unidos, 28602
- Unifour Medical Research Associates, LLC
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Raleigh, North Carolina, Estados Unidos, 27609
- PMG Research of Raleigh, LLC
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Salisbury, North Carolina, Estados Unidos, 28144
- PMG Research of Salisbury
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Winston-Salem, North Carolina, Estados Unidos, 27103
- PMG Research of Winston-Salem
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45206
- Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
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Cleveland, Ohio, Estados Unidos, 44122
- Rapid Medical Research, Inc.
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Franklin, Ohio, Estados Unidos, 45005
- Prestige Clinical Research
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Pennsylvania
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Carnegie, Pennsylvania, Estados Unidos, 15106
- Preferred Primary Care Physicians, Inc
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Grove City, Pennsylvania, Estados Unidos, 16127
- Family Healthcare Partners
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Jefferson Hills, Pennsylvania, Estados Unidos, 15025
- Family Practice Medical Associates South, Jefferson Office
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Pittsburgh, Pennsylvania, Estados Unidos, 15241
- Primary Physicians Research Inc.
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Pittsburgh, Pennsylvania, Estados Unidos, 15217
- Kid's Plus Pediatrics
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Upper St. Clair, Pennsylvania, Estados Unidos, 15241
- Family Practice Medical Associates South
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Washington, Pennsylvania, Estados Unidos, 15301
- The Washington Hospital Family Medicine
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Tennessee
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Bristol, Tennessee, Estados Unidos, 37620
- PMG Research of Bristol, LLC
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Bristol, Tennessee, Estados Unidos, 37620
- Internal Medicine & Pediatric Associates of Bristol, PC
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Knoxville, Tennessee, Estados Unidos, 37920
- Volunteer Research Group
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Texas
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Houston, Texas, Estados Unidos, 77055-6040
- Clark D. McKeever, M.D. Research for Health
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San Antonio, Texas, Estados Unidos, 78229
- Diagnostics Research Group
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Utah
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West Jordan, Utah, Estados Unidos, 84088
- Advanced Clinical Research
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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
50 anos a 59 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male or female aged 50 to 59 years
- Determined by medical history, physical examination and clinical judgement to be eligible for the study
- Able to complete electronic diary
- Available for the 5 year 9 month duration of the study
Exclusion Criteria:
- Previous vaccination with any licensed or experimental pneumococcal vaccine
- Allergic to egg proteins and chicken proteins
- History of Guillian-Barre syndrome
- Vaccination with TIV within 6 months before study start
- Vaccination with diphtheria-containing vaccine within 6 months of study start
- Serious chronic disorders including immunodeficiency or metastatic malignancy
- Known or suspected hypersensitivity to any vaccine or vaccine component
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: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 1
arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
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TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Outros nomes:
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Outros nomes:
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Outro: 2
arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
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TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Outros nomes:
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Outros nomes:
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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 at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Prazo: 1 month after Dose 1
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Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated.
N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen.
n=participants who met the prespecified level for the given antigen.
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1 month after Dose 1
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Prazo: 1 month after 13vPnC Dose at year 0
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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1 month after 13vPnC Dose at year 0
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
Prazo: 1 month after 13vPnC (Year 5)
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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1 month after 13vPnC (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants with immunogenicity data at both Year 5 endpoints.
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before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
Prazo: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants
with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
Prazo: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
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before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
Prazo: before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
Prazo: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay.
GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.
CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.
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Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
Prazo: Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both the baseline and the various time points.
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Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
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Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)
Prazo: 1 month after 13vPnC (Year 5)
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated.
Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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1 month after 13vPnC (Year 5)
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both Year 5 time points.
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before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
Prazo: before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points
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1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
Prazo: 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Prazo: before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw.
CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
|
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
|
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
Prazo: Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
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Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
Prazo: Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV).
Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
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Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
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Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
Prazo: Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results.
CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises.
GMFRs were calculated using all participants with available data from both the baseline and the various time points.
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Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
Prazo: Within 14 days after Dose 1 (Year 0)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 14 days after Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
Prazo: Within 14 days after Dose 2 (Year 0)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 14 days after Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
Prazo: Within 14 days after 13vPnC (Year 5)
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Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm).
Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity).
Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
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Within 14 days after 13vPnC (Year 5)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
Prazo: Within 14 days after Dose 1 (Year 0)
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Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
Prazo: Within 14 days after Dose 2 (Year 0)
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Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
Prazo: Within 14 days after 13vPnC (Year 5)
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Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
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Within 14 days after 13vPnC (Year 5)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
Prazo: Within 30 Minutes After Dose 1 (Year 0)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 30 Minutes After Dose 1 (Year 0)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
Prazo: Within 30 Minutes After Dose 2 (Year 0)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
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Within 30 Minutes After Dose 2 (Year 0)
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Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
Prazo: Within 30 Minutes After 13vPnC (Year 5)
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Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
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Within 30 Minutes After 13vPnC (Year 5)
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Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
Prazo: Signing of informed consent up to 194 days after re-vaccination at Year 5
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Non-serious AEs are AEs excluding SAEs.
In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.
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Signing of informed consent up to 194 days after re-vaccination at Year 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.
Publicações Gerais
- Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
- Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.
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 setembro de 2007
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de dezembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de agosto de 2007
Primeira postagem (Estimativa)
28 de agosto de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
9 de abril de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de abril de 2015
Última verificação
1 de abril de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6115A1-3001
- B1851020 (Outro identificador: Alias Study Number)
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 .