A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
21 de março de 2019 atualizado por: Merck Sharp & Dohme LLC
A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
338
Estágio
- Fase 2
- Fase 1
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
2 meses a 49 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
Adult Cohort: 18 to 49 years and in good health
- Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
Exclusion Criteria:
Adult cohort: Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- Received a blood transfusion or blood products within 6 months
- Participated in another clinical study of an investigational product within 2 months
- Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- History of congenital or acquired immunodeficiency
- Has or mother has documented Human Immunodeficiency virus (HIV) infection
- Has or mother has documented hepatitis B surface antigen positive result
- Functional or anatomic asplenia
- History of failure to thrive
- Coagulation disorder contraindicating intramuscular vaccination
- History of autoimmune disease or autoimmune disorder
- Known neurologic or cognitive behavioral disorder
- Received systemic corticosteroids within 14 days
- Received other licensed non-live vaccine within 14 days
- Received other licensed live virus vaccine within 30 days
- Received a blood transfusion or blood products
- Participated in another clinical study of an investigational product
- History of invasive pneumococcal disease
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Adult: V114 Medium Dose
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
|
|
Experimental: Adult: V114 High Dose
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
|
|
Experimental: Adult: V114 Medium Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
|
|
Experimental: Adult: V114 High Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
|
|
Experimental: Infant: V114 Medium Dose
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
|
|
Experimental: Infant: V114 High Dose
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
|
|
Experimental: Infant: V114 Medium Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
|
|
Experimental: Infant: V114 High Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
|
|
Comparador Ativo: Infant: Prevnar 13™
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.
|
Vacina pneumocócica 13-valente conjugada com sorotipos 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2,2 mcg) e 6B (4,4 mcg) em cada dose de 0,5 ml
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adults: Percentage of Participants With an Adverse Event
Prazo: Up to 6 weeks after vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to 6 weeks after vaccination
|
|
Infants: Percentage of Participants With an Adverse Event
Prazo: Up to 1 month after Vaccination 4 (Month 11-15)
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to 1 month after Vaccination 4 (Month 11-15)
|
|
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
Prazo: Up to time of Vaccination 4 (Month 10-13)
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to time of Vaccination 4 (Month 10-13)
|
|
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Prazo: Up to 14 days after any vaccination
|
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
|
Up to 14 days after any vaccination
|
|
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Prazo: Up to 14 days after any vaccination
|
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
|
Up to 14 days after any vaccination
|
|
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Prazo: 1 month after Vaccination 3 (Month 5)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 3 (Month 5)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Prazo: 1 month after vaccination
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after vaccination
|
|
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Prazo: Baseline and 1 month after vaccination
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
|
Baseline and 1 month after vaccination
|
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Prazo: 1 month after Vaccination 3 (Month 5)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 3 (Month 5)
|
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Prazo: Before Vaccination 4 (Month 10-13)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
Before Vaccination 4 (Month 10-13)
|
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Prazo: 1 month after Vaccination 4 (Month 11-15)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 4 (Month 11-15)
|
|
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Prazo: Before Vaccination 4 (Month 10-13)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
Before Vaccination 4 (Month 10-13)
|
|
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Prazo: 1 month after Vaccination 4 (Month 11-15)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 4 (Month 11-15)
|
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 (Real)
15 de setembro de 2015
Conclusão Primária (Real)
14 de abril de 2017
Conclusão do estudo (Real)
14 de abril de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
20 de agosto de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de agosto de 2015
Primeira postagem (Estimativa)
24 de agosto de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de abril de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V114-005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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