Estudo de Consistência Lote-a-Lote de uma Vacina Pneumocócica Conjugada 21-Valente em Bebés Saudáveis a Partir dos 2 Meses de Idade
Um Estudo de Fase 3, Randomizado, Duplo-cego Modificado, Controlado Ativo, de Grupos Paralelos, de Consistência de Lote para Lote, com 4 Braços para Investigar a Segurança e Imunogenicidade de um Regime de 4 Doses de uma Vacina Pneumocócica Conjugada 21-Valente em Lactentes e Crianças Saudáveis
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Trial Transparency email recommended (Toll free for US & Canada)
- Número de telefone: option 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Locais de estudo
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Recrutamento
- Northwest Arkansas Pediatric Clinic- Site Number : 8400039
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California
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Huntington Park, California, Estados Unidos, 90255
- Recrutamento
- Matrix Clinical Research - Huntington Park- Site Number : 8400029
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Los Angeles, California, Estados Unidos, 90008
- Recrutamento
- Community Clinical Research- Site Number : 8400030
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Los Angeles, California, Estados Unidos, 90057
- Recrutamento
- Matrix Clinical Research - Los Angeles- Site Number : 8400028
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Florida
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Tampa, Florida, Estados Unidos, 33613
- Recrutamento
- PAS Research - Tampa- Site Number : 8400034
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Recrutamento
- Kentucky Pediatric Research- Site Number : 8400036
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Michigan
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Allen Park, Michigan, Estados Unidos, 48101
- Recrutamento
- Michigan Institute of Research- Site Number : 8400004
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New York
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Syracuse, New York, Estados Unidos, 13210
- Recrutamento
- Nappi Wellness Institute\t- Site Number : 8400037
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Recrutamento
- Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
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Simpsonville, South Carolina, Estados Unidos, 29681
- Recrutamento
- Parkside Pediatrics - Simpsonville- Site Number : 8400005
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Spartanburg, South Carolina, Estados Unidos, 29301
- Recrutamento
- Tribe Clinical Research - Spartanburg- Site Number : 8400026
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Texas
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Edinburg, Texas, Estados Unidos, 78539
- Recrutamento
- PAS Research - Children's Care Clinic- Site Number : 8400035
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Richmond, Texas, Estados Unidos, 77469
- Recrutamento
- Pediatric Center - Richmond- Site Number : 8400038
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Utah
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Ogden, Utah, Estados Unidos, 84404
- Recrutamento
- Rio Clinical Trials - Canyon View- Site Number : 8400031
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San Pedro Sula, Honduras, 21104
- Recrutamento
- Investigational Site Number : 3400001
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Tegucigalpa, Honduras, 11101
- Recrutamento
- Investigational Site Number : 3400003
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Tegucigalpa, Honduras, 11101
- Recrutamento
- Investigational Site Number : 3400002
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Guayama, Porto Rico, 00786
- Recrutamento
- Investigational Site Number : 6300005
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San Juan, Porto Rico, 00918
- Recrutamento
- Investigational Site Number : 6300006
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Trujillo Alto, Porto Rico, 00976
- Recrutamento
- Investigational Site Number : 6300007
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Bangkok, Tailândia, 10400
- Recrutamento
- Investigational Site Number : 7640002
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Chiang Mai, Tailândia, 50180
- Recrutamento
- Investigational Site Number : 7640004
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Hat Yai, Tailândia, 90110
- Recrutamento
- Investigational Site Number : 7640003
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Khon Kaen, Tailândia, 40002
- Recrutamento
- Investigational Site Number : 7640001
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Pathum Wan, Tailândia, 10330
- Recrutamento
- Investigational Site Number : 7640005
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged 42 to 89 days on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
Exclusion Criteria:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group 1: PCV21
Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Outros nomes:
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Experimental: Group 2: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Outros nomes:
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Experimental: Group 3: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Outros nomes:
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Comparador Ativo: Group 4: 20vPCV (Cohort A only)
Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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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For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
Prazo: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL) |
30 days after the third dose of PCV21 vaccine
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
Prazo: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL |
30 days after the third dose of PCV21 vaccine
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For all participants: Presence of any immediate adverse events (AEs)
Prazo: Within 30 minutes after each vaccine injection
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Number of participants experiencing immediate AEs |
Within 30 minutes after each vaccine injection
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For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Prazo: Through 7 days after each vaccine injection
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Number of participants experiencing solicited injection site and systemic reactions |
Through 7 days after each vaccine injection
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For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
Prazo: Through 30 days after each vaccine injection
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Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs |
Through 30 days after each vaccine injection
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For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Prazo: Throughout the study (through 6 months post-last vaccine injection)
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Number of participants experiencing SAEs and AESIs |
Throughout the study (through 6 months post-last vaccine injection)
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PSK00029
- PSK00029 (Outro identificador: Sanofi Identifier)
- U1111-1308-6832 (Outro identificador: WHO ICTRP)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Informações sobre medicamentos e dispositivos, documentos de estudo
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