A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
22 de janeiro de 2013 atualizado por: Pfizer
A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone.
Group 2 subjects will also receive catch-up doses of 7vPnC.
The study vaccines will be open-label.
The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone.
In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
321
Estágio
- Fase 4
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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Chiba, Japão
- Tsubaki Children's Clinic
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Fukuoka, Japão
- Kiyomatsu Childrens Clinic
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Fukuoka, Japão
- National Hospital Organization Fukuoka National Hospital
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Fukuoka, Japão
- Shindo children's clinic
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Fukuoka, Japão
- Takasaki Clinic Pedatrics and Child Health
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Chiba
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Isumi-city, Chiba, Japão
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city, Ehime, Japão
- Matsuyama Red Cross Hospital
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Fukuoka
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Itoshima, Fukuoka, Japão
- Yamashita Pediatrics Clinic
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Kasuga, Fukuoka, Japão
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Japão
- Furuta Children's Clinic
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Sapporo, Hokkaido, Japão
- Watanabe Pediatric Allergy Clinic
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Sapporo, Hokkaido, Japão
- Yamanaka Tatsuru Pediatrics
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Sapporo-city, Hokkaido, Japão
- Tenshi Hospital
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Mie
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Kuwana, Mie, Japão
- Matsuda Pediatrics Clinic
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Okayama
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Kurashiki, Okayama, Japão
- Kawasaki Medical School, Department of Pediatrics
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Okayama-city, Okayama, Japão
- Momotaro Clinic
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Osaka
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Toyonaka, Osaka, Japão
- Hug Hug Kids Clinic
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Saitama
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Kumagaya-city, Saitama, Japão
- Shibuya Clinic
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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
3 meses a 6 meses (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
- History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
- Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
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 Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
Experimental
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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Experimental: 2
Active comparator
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0.5 mL per dose, 4 doses
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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 Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Prazo: 1 month after the infant series
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Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented.
Exact 2-sided CI based on the observed proportion of participants.
Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Prazo: 1 month after the infant series
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Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Prazo: 1 month after the infant series
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GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the infant series
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Prazo: 1 month after the infant series
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
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1 month after the infant series
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Prazo: 1 month after the infant series
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Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% CI were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
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1 month after the infant series
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Prazo: 1 month after the toddler dose
|
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented.
Exact 2-sided CI based on the observed proportion of participants.
Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Prazo: 1 month after the toddler dose
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GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Prazo: 1 month after the toddler dose
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GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the toddler dose
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Prazo: 1 month after the toddler dose
|
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
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1 month after the toddler dose
|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Prazo: 1 month after the toddler dose
|
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% CIs were evaluated.
GMs were calculated using all participants with available data for the specified blood draw.
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1 month after the toddler dose
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Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Prazo: Pre-toddler dose, 1 month after the toddler dose
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Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
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Pre-toddler dose, 1 month after the toddler dose
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Prazo: 1 month after the catch-up dose 3
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
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1 month after the catch-up dose 3
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Prazo: 1 month after the catch-up dose 3
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Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% CI were evaluated.
GMs were calculated using all participants with available data for the specified blood draw.
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1 month after the catch-up dose 3
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Prazo: Within 7 days after Dose 1 of the infant series
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Dose 1 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Prazo: Within 7 days after Dose 2 of the infant series
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Dose 2 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Prazo: Within 7 days after Dose 3 of the infant series
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Dose 3 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Prazo: Within 7 days after the toddler dose
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after the toddler dose
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Prazo: Within 7 days after Catch-up Dose 1
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Catch-up Dose 1
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Prazo: Within 7 days after Catch-up Dose 2
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Catch-up Dose 2
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Prazo: Within 7 days after Catch-up Dose 3
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Catch-up Dose 3
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Prazo: Within 7 days after Dose 1 of the infant series
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Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Dose 1 of the infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Prazo: Within 7 days after Dose 2 of the infant series
|
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Dose 2 of the infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Prazo: Within 7 days after Dose 3 of the infant series
|
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Dose 3 of the infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Prazo: Within 7 days after the toddler dose
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Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after the toddler dose
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Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Prazo: Within 7 days after Catch-up Dose 1
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Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Catch-up Dose 1
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Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Prazo: Within 7 days after Catch-up Dose 2
|
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Catch-up Dose 2
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Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Prazo: Within 7 days after Catch-up Dose 3
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Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after Catch-up Dose 3
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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 novembro de 2010
Conclusão Primária (Real)
1 de março de 2012
Conclusão do estudo (Real)
1 de março de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
29 de novembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de novembro de 2010
Primeira postagem (Estimativa)
1 de dezembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de fevereiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de janeiro de 2013
Última verificação
1 de janeiro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B1841007
- B1841007, 6107A1-4000
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 .