| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion |
|
| E.1.1.1 | Medical condition in easily understood language |
| Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054187 |
| E.1.2 | Term | Polio immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10069543 |
| E.1.2 | Term | Hemophilus influenzae type b immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10069593 |
| E.1.2 | Term | Pertussis immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054181 |
| E.1.2 | Term | Hepatitis B immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054180 |
| E.1.2 | Term | Diphtheria immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054183 |
| E.1.2 | Term | Tetanus immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| 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 |
The two co-primary objectives for the study are:
-To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (% of subjects with an anti-HBs titre ≥10 mIU/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7)
-To demonstrate that the mixed schedule induces acceptable responses for Hib (% of subjects with an anti-PRP titre ≥0.15 µg/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7). |
Los dos objetivos principales del estudio son:
− Demostrar que el esquema alternado induce respuestas aceptables frente
a la hepatitis B (porcentaje de pacientes con un título de anticuerpos
frente al antígeno de superficie de la hepatitis B [anti-HBs] ≥ 10 mUI/ml)
un mes después de la tercera dosis del esquema alternado (p. ej., al
séptimo mes)
− Demostrar que el esquema alternado induce respuestas aceptables frente
a Hib (porcentaje de pacientes con un título de anticuerpos de PRP ≥
0,15 μg/ml) un mes después de la tercera dosis del esquema alternado
(p. ej., al séptimo mes) |
|
| E.2.2 | Secondary objectives of the trial |
Immunogenicity:
-To describe the antibody response to all PR5I antigens: hepatitis B, Hib, diphtheria (D) and tetanus (T) toxoids, pertussis (PT, FHA, PRN, FIM 2&3) and inactivated poliovirus antigens (IPV1, IPV2, IPV3) one month after completion of the mixed schedule (i.e. at Month 7).
-To describe the antibody response to meningococcal serogroup C conjugate (MenC) vaccine one month after the second dose of MenC vaccine when used concomitantly with the mixed schedule.
Safety:
- To describe the safety profile after each dose of study vaccines administered. |
Inmunogenicidad:
-Describir la respuesta de los anticuerpos a todos los antígenos de PR5I:
hepatitis B, Hib, difteria (D) y toxoides tétanicos (T), tosferina (TP, HAF,
PRN, FIM 2 y 3) y antígenos del virus de la poliomelitis inactivado (IPV1,
IPV2, IPV3) un mes después de completar el esquema alternado (es decir, en
el mes 7).
-Describir la respuesta de los anticuerpos a la vacuna antimeningocócica del
serogrupo C conjugada (MenC) un mes después de la segunda dosis de la
vacuna MenC, cuando se usa de manera concomitante con un esquema
alternado.
Seguridad:
-Describir el perfil de seguridad después de cada dosis de las vacunas
administradas en el estudio. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1.Subject is a healthy infant greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion.
2.Subject has received only one dose of monovalent hepatitis B vaccine, within the 3 days after birth, outside of the study context and it is documented in subject´s medical history.
3.Informed consent has been signed by the subject's parent(s) or legal representative.
4.Subject's parent(s) or legal representative able to comply with the study procedures such as adherence to study visits and completion of the Vaccination Report Cards. |
1. El paciente es un bebé sano de 46 o más días de edad y que no tiene más de
74 días de edad el día de la inclusión.
2. El paciente ha recibido solo una dosis de la vacuna monovalente contra la
hepatitis B en los 3 días siguientes al nacimiento, fuera del contexto del
estudio, y esta vacunación está registrada en la historia clínica del paciente.
3. Los padres o el representante legal del paciente han firmado el
consentimiento informado
4. Los padres o el representante legal del paciente son capaces de cumplir con
los procedimientos del estudio, como la asistencia a las visitas y la
cumplimentación de las Tarjetas de Registro de Vacunación. |
|
| E.4 | Principal exclusion criteria |
1.Participation in any study with an investigational compound or device since birth
2.Subject´s parent(s)/legal representative plans to enrol the subject in another clinical study during the present study period
3.History of congenital or acquired immunodeficiency (e.g. HIV)
4.Chronic illness that could interfere with study conduct or completion, or significant findings on review of systems (by medical history) such as development delay or neurological disorder
5.Known or suspected hypersensitivity to any of the study vaccines' components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
6.Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® as per their Summary of Product Characteristics
7.History or maternal history of HBsAg seropositivity
8.Coagulation disorder that contraindicate intramuscular injection
9.History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
10.History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
11.Receipt of immune globulin, blood or blood-derived products since birth
12.Receipt of systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days within one month of the study start
13.Subjects expected to require systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days from the time of study start through the end of the safety follow-up period following the last dose. Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, and inhaled) will be eligible for vaccination.
14.Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study. |
1. Participación en un estudio con un compuesto o un producto sanitario en fase
de investigación desde el nacimiento.
2. Los padres o el representante legal del paciente tienen previsto incluirlo en
otro estudio clínico durante el periodo de este estudio.
3. Antecedentes de inmunodeficiencia congénita o adquirida (p.ej., VIH)
4. Enfermedad crónica que pudiera interferir en la realización o finalización del
estudio, o resultados relevantes en la revisión de sistemas orgánicos
(mediante anamnesis), como por ejemplo retraso en el desarrollo o trastorno
neurológico.
5. Hipersensibilidad conocida o sospechada a cualquiera de los componentes de
las vacunas del estudio, o antecedentes de una reacción potencialmente
mortal a una vacuna que contiene los mismos principios activos que las
vacunas del estudio.
6. Contraindicación a Pediacel®, NeisVac-C®, Prevenar 13® y RotaTeq® según
sus Fichas Técnicas.
7. Antecedentes o antecedentes maternos de seropositividad al HBsAg
8. Trastorno de coagulación por el cual la inyección intramuscular esté
contraindicada.
9. Antecedentes de vacunación con vacunas contra Haemophilus influenzae tipo
b conjugado, difteria, tétanos, tosferina (acelular o de células enteras), virus
de la poliomelitis, antimeningocócica del serogrupo C conjugada,
antineumocócica conjugada.
10. Antecedentes de infección por hepatitis B, Haemophilus influenzae tipo b,
difteria, tétanos, tosferina, virus de la poliomielitis, o infección meningocócica
del serogrupo C.
11. Pacientes que hayan recibido inmunoglobulina, sangre o hemoderivados desde el nacimiento.
12. Pacientes que hayan recibido corticoesteroides sistémicos (en cantidades
superiores al equivalente a una dosis diaria total de prednisona de 2 mg/kg)
durante más de 14 días consecutivos en el mes previo al del inicio del
estudio.
13. Pacientes que se espera que requieran corticoesteroides sistémicos (más que
lo equivalente a una dosis diaria total de prednisona de 2 mg/kg) durante
más de 14 días consecutivos desde el momento de inicio del estudio hasta el
final del periodo de seguimiento de la seguridad posterior a la última dosis.
Los pacientes que usen corticoesteroides no sistémicos (p. ej., tópicos,
oftálmicos e inhalados) serán aptos para la vacunación.
14. Pacientes que sean hijos naturales o adoptados del investigador o de un
empleado directamente implicado en el estudio. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
-Proportion of subjects with an anti-HBs titre ≥10 mIU/mL
-Proportion of subjects with an anti-PRP titre ≥0.15 µg/mL |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One month after the complete mixed schedule PR5I/Pediacel/PR5I |
|
| E.5.2 | Secondary end point(s) |
Immunogenicity:
-Anti-HBs Geometric Mean Titers (GMT)
-Anti-PRP GMT
-Proportion of subjects with an anti-PRP titre ≥1 µg/mL
-Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
-Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
-Anti-diphtheria Geometric Mean Concentrations (GMC)
-Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
-Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
-Anti-tetanus GMC
-Proportion of subjects with an anti-IPV1 titre ≥1:8 dil
-Proportion of subjects with an anti-IPV2 titre ≥1:8 dil
-Proportion of subjects with an anti-IPV3 titre ≥1:8 dil
-Anti-IPV1, anti-IPV2 and anti-IPV3 GMTs
-Anti-PT , anti-FHA, anti-PRN and anti-FIM 2&3 GMCs
-Proportion of subjects with an anti-MenC titre ≥ 1:8dil
-Anti-MenC GMT
Safety:
Incidence of solicited injection-sites reactions and solicited systemic adverse event.
Incidence of unsolicited injection-site reactions, unsolicited systemic adverse events and all serious adverse events. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity: one month after the complete mixed schedule PR5I/Pediacel/PR5I and one month after the second dose of MenC vaccine.
Safety: from Visit 1 to Visit 5 |
|
| 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 | Yes |
| 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 | No |
| 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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 | No |
| 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
|
| End of data collection including availability of last serololgy results |
|
| 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 | 1 |
| 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 | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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