E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
3-dose primary vaccination against Streptococcus pneumoniae and Haemophilus influenzae in healthy infants between 6-12 weeks of age at the time of the first vaccination and booster vaccination at 12-15 months of age. |
Vacunación primaria con tres dosis frente a Streptococcus pneumoniae (S. pneumoniae) y Haemophilus influenzae (H. influenzae) en lactantes sanos de 6 a 12 semanas (42-90 días) en el momento de la primera vacunación, seguida de una dosis de recuerdo a los 12-15 meses de vida. |
|
E.1.1.1 | Medical condition in easily understood language |
Vaccination against pneumococcal and Haemophilus influenzae diseases of healthy infants. |
Vacunación frente neumococo y Haemophilus influenzae en lactantes sanos |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018953 |
E.1.2 | Term | Haemophilus influenzae meningitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042194 |
E.1.2 | Term | Streptococcus pneumoniae meningitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042196 |
E.1.2 | Term | Streptococcus pneumoniae secondary bacterial infection of acute bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018954 |
E.1.2 | Term | Haemophilus influenzae secondary bacterial infection of acute bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018952 |
E.1.2 | Term | Haemophilus influenzae infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035680 |
E.1.2 | Term | Pneumonia due to Haemophilus influenzae (H. influenzae) |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054642 |
E.1.2 | Term | Streptococcus pneumoniae septicemia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042195 |
E.1.2 | Term | Streptococcus pneumoniae pneumonia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058214 |
E.1.2 | Term | Septicaemia due to haemophilus influenzae (H. influenzae) |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042197 |
E.1.2 | Term | Streptococcus pneumoniae septicaemia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
? To demonstrate that 2830929A vaccine co-administered with DTPa-HBV-IPV/Hib as a three-dose primary vaccination course at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA Geometric Mean Concentrations (GMCs).
? To demonstrate that 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA GMCs. |
?Demostrar que la vacuna 2830929A, coadministrada con DTPa-HBV-IPV/Hib en una pauta de vacunación primaria con tres dosis aproximadamente a los 2, 3 y 4 meses de vida es no inferior a Prevenar 13 ó a Synflorix, de acuerdo al porcentaje de sujetos con una concentración de anticuerpos mayor o igual a 0,20 µg/ml.y de acuerdo a las concentraciones medias geométricas (GMCs) de ELISA. ?Demostrar que la vacuna 2830930A, coadministrada con DTPa-HBV-IPV/Hib en una pauta de vacunación primaria con tres dosis aproximadamente a los 2, 3 y 4 meses de vida es no inferior a Prevenar 13 ó a Synflorix, de acuerdo al porcentaje de sujetos con una concentración de anticuerpos mayor o igual a 0,20 µg/ml.y de acuerdo a las GMCs de ELISA |
|
E.2.2 | Secondary objectives of the trial |
? To assess the immune responses to components of the 2830929A and 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib vaccine after 3-dose primary vaccination course in infants at 2, 3, 4 months of age and after a booster vaccination at 12-15 months of age.
? To assess the antibody persistence induced by 2830929A and 2830930A vaccines, 8-11 months after completion of the 3-dose primary vaccination course.
? To assess the safety and reactogenicity of 2830929A and 2830930A vaccines after administration of any primary and booster vaccine dose when co-administered with DTPa-HBV-IPV/Hib. |
?Evaluar las respuestas inmunitarias a los componentes de las vacunas 2830929A y 2830930A, coadministradas con la vacuna DTPa-HBV-IPV/Hib después de una pauta de vacunación primaria con 3 dosis en lactantes aproximadamente a los 2, 3 y 4 meses de vida y tras administrar una dosis recuerdo a los 12-15 meses de edad. ?Evaluar la persistencia de los anticuerpos inducidos por las vacunas 2830929A y 2830930A, entre 8 y 11 meses después de terminar la pauta de vacunación primaria con 3 dosis. ?Evaluar la seguridad y reactogenicidad de las vacunas 2830929A y 2830930A, tras la administración de cualquier dosis de la vacunación primaria y de recuerdo, cuando se coadministra con DTPa-HBV-IPV/Hib. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol. ? A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. ? Written informed consent obtained from the parents/LAR(s) of the subject. ? Healthy subjects as established by medical history and clinical examination before entering into the study. ? Born after a gestation period of at least 36 weeks. |
?Sujetos cuyos padres/representantes legales aceptables (RLA) puedan y deseen cumplir los requisitos del protocolo ?Niños o niñas de entre 6 y 12 semanas (42-90 días) de edad en el momento de la primera vacunación. ?Firma del consentimiento por los padres o tutores legales del sujeto. ?Sujetos sanos, según lo establecido en la historia clínica y exploración física previas a la entrada en el estudio. ?Nacimiento tras un periodo mínimo de gestación de 36 semanas. |
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E.4 | Principal exclusion criteria |
? Child in care. ? Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. ? Chronic administration of immunosuppressants or other immune-modifying drugs since birth. ? Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions: - Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines. - Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines. - Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age. - In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. ? Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product ? Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination ? Family history of congenital or hereditary immunodeficiency. ? History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). ? Major congenital defects or serious chronic illness, including Kawasaki?s syndrome. ? History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile). ? Acute disease and/or fever at the time of enrolment. ? Administration of immunoglobulins and/or any blood products since birth or planned administration during study period. ? Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b. ? Previous vaccination against S. pneumoniae. ? History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease. ? Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator. |
-Niño/a en situación de acogida -Uso de un producto (medicamento o vacuna) en investigación o no registrado, diferente de la(s) vacuna(s) del estudio, en los 30 días anteriores a la administración de la primera dosis de la vacuna del estudio o uso previsto durante el periodo de estudio. -Administración prolongada de inmunosupresores u otros inmunomoduladores desde el nacimiento. -Administración prevista/administración de una vacuna que contenga el toxoide diftérico, toxoide tetánico (excepto MenC-TT en España) o CRM197 y que no esté prevista en el protocolo en ningún período del estudio, o de cualquier otra vacuna no prevista en el protocolo desde 30 días antes de administrar cada dosis de la vacuna de estudio hasta 30 días después, con excepción de: -Las vacunas antigripales autorizadas se permiten siempre, incluso si se administran al mismo tiempo que las vacunas del estudio. -La vacuna antirrotavirus autorizada está permitida si se administra por lo menos 7 días antes o después de cada dosis de las vacunas del estudio. -La vacuna MenCC-TT autorizada se permitirá a los sujetos en España y se deberá administrar al mismo tiempo que la vacuna del estudio aproximadamente a los 2, 4 y 12-15 meses de edad. -Si las autoridades sanitarias organizan la vacunación masiva de urgencia ante una amenaza no prevista para la salud pública (p. ej., una pandemia), fuera del calendario de vacunación sistemático, la vacuna se podrá administrar en cualquier momento del periodo de estudio, siempre que esté autorizada y se use de acuerdo con la Ficha Técnica del producto ó prospecto, y de acuerdo con las recomendaciones gubernamentales locales, y siempre que el promotor conceda su aprobación por escrito. La administración de cualquiera de las vacunas mencionadas más arriba tiene que ser documentada en la sección de "Vacunación concomitante" del CRDe. -Participación simultánea, en cualquier momento durante el periodo del estudio, en otro ensayo clínico en el que el sujeto haya sido o será expuesto a un producto en investigación o de naturaleza no experimental (producto farmacéutico o sanitario). -Cualquier estado de inmunosupresión o inmunodeficiencia conocido o sospechado por la historia clínica y la exploración física (no se exigirá ninguna prueba de laboratorio). -Antecedentes familiares de inmunodeficiencia congénita o hereditaria. -Antecedentes de reacción o de hipersensibilidad posiblemente exacerbada por algún componente de la(s) vacuna(s) . -Defectos congénitos importantes o enfermedades crónicas graves, incluido el síndrome de Kawasaki. -Antecedentes de enfermedades neurológicas o de crisis convulsivas, incluidos los trastornos como episodios de hipotensión o hiporreactividad, encefalopatía o cualquier tipo de convulsión (afebril y febril). -Enfermedad aguda y/o fiebre en el momento del reclutamiento. -Administración de inmunoglobulinas y/o cualquier hemoderivado desde el nacimiento o administración prevista durante el periodo de estudio -Vacunación previa frente a la difteria, tétanos, tos ferina, polio, H. influenzae de tipo b. -Vacunación previa frente a S. pneumoniae. -Antecedentes de difteria, tétanos, tos ferina, hepatitis B, polio o enfermedad por H. influenzae de tipo b. -Cualquier enfermedad que, en opinión del investigador, pudiera interferir en la evaluación de los objetivos del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of immune responses to components of the 2830929A and 2830930A vaccines |
Evaluación de las respuestas inmunitarias a los componentes de las vacunas 2830929A y 2830930A |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month post-dose 3 (Month 3) |
un mes tras las dosis 3 (mes 3) |
|
E.5.2 | Secondary end point(s) |
Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines, for additional parameters. - Concentrations of antibodies and opsonophagocityc activity against all components of the investigational pneumococcal vaccines. Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines. - Concentrations of antibodies against all components of the investigational pneumococcal vaccines. Occurrence of each solicited adverse event - Solicited local adverse events (any and grade 3) - Solicited general adverse events (any, grade 3 and related) Occurrence of each unsolicited adverse event Occurrence of serious adverse event |
?Inmunogenicidad frente a los componentes de las vacunas 2830929A y 2830930A en investigación, para parámetros adicionales -Concentración de los anticuerpos y actividad opsonofagocítica frente a los serotipos neumocócicos vacunales ?Inmunogenicidad frente a los componentes de las vacunas 2830929A y 2830930A en investigación, -Concentración de anticuerpos frente a los serotipos neumocócicos vacunales ?Frecuencia de cada acontecimiento adverso solicitado en los 4 días (días 0-3) siguientes a la administración de cada dosis de vacuna ?Síntomas locales solicitados (cualquiera, grado 3). ?Síntomas generales solicitados (cualquiera, grado 3, relacionados). ?Frecuencia de acontecimientos adversos no solicitados en los 31 días (días 0-30) siguientes a cada vacunación. ?Frecuencia de acontecimientos adversos graves durante todo el período de estudio (desde el mes 0 hasta el mes 11). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- One month post-dose 3 (Month 3) and one month post-booster vaccination (Month 11) - Prior to booster vaccination (Month 10) - Within 4 days (Day 0-Day 3) after each - Within 31 days (Day 0-Day 30) after each vaccination - During the entire study (from Month 0 up to Month 11) |
-Un mes tras la dosis 3 (mes 3) y un mes tras la administración de la dosis de recuerdo (mes 11) - Antes de la administración de la dosis de recuerdo (mes 10) - En los 4 días siguientes (día 0-día 3) a la administración de cada dosis de vacuna - En los 31 días siguientes (día 0-día 30) a la administración de cada dosis de vacuna - Durante todo el periodo de estudio (desde el mes 0 al mes 11) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity |
Inmunogenicidad |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
parcialmente ciego |
partially-blind |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last subject last visit |
Último sujeto última visita |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |