| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (immunisation against diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b) |
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| E.1.1.1 | Medical condition in easily understood language |
| Diphtheria, Tetanus, pertussis (whooping cough), Polio, Bacterial meningitis and other invasive bacterial disease. |
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| 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 | 19.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10021881 |
| E.1.2 | Term | Infections and infestations |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| 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 assess the immune response to the study vaccine in terms of seroprotection status for diphtheria, tetanus, Hib and poliovirus types 1, 2 and 3 antigens, and in terms of sero-positivity to the pertussis antigens, one month after the third dose of primary vaccination |
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| E.2.2 | Secondary objectives of the trial |
To assess the immune response to the study vaccine in terms of seroprotection to diphtheria, tetanus, Hib and poliovirus types 1, 2 and 3 antigens, and in terms of seropositivity to the pertussis antigens, one month after the booster vaccination.
To assess the immune response to the study vaccine in terms of antibody concentrations or titres against diphtheria, tetanus, Hib, poliovirus types 1, 2 and 3 antigens, and pertussis antigens, one month after the third dose of primary vaccination and one month after the booster vaccination.
To assess the safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs)
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|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Subjects’ parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female child between 3 and 4 months of age at the time of the first vaccination.
• Written informed consent obtained from the parents/adoptive parent(s) of the subject prior to performing any study specific procedure.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term
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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 during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
• 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 vaccine/product
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
• History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
• 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.
• Major congenital defects.
• Serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >= 37.5°C for oral, axillary or tympanic route, or >= 38.0°C for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1) Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti T)
A seroprotected subject is defined as a subject with anti-D/anti-T antibody concentrations greater than or equal to (≥) 0.1 International Units per millilitre (IU/mL).
2) Number of seroprotected subjects against anti-poliovirus (anti-polio) types 1, 2 and 3
A seroprotected subject is defined as a subject with anti-polio antibody titres ≥ 8
3) Number of seroprotected subjects against anti-polyribosyl ribitol phosphate (anti-PRP).
A seroprotected subject is defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per millilitre (µg/mL)
4) Number of seropositive subjects for anti-pertussis (anti- PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).
A seropositive subject is defined as a subject whose antibody concentration/titre is ≥ to the assay cut-off. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) At Month 4.
2) At Month 4.
3) At Month 4.
4) At Month 4. |
|
| E.5.2 | Secondary end point(s) |
1) Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti T).
A seroprotected subject is defined as a subject with anti-D/anti-T antibody concentrations ≥ 0.1 International Units per millilitre (IU/mL).
2) Number of seroprotected subjects against anti-poliovirus (anti-polio) types 1, 2 and 3.
A seroprotected subject is defined as a subject with anti-polio antibody titres ≥ 8.
3)Number of seroprotected subjects against anti-polyribosyl ribitol phosphate (anti-PRP).
A seroprotected subject is defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per millilitre (µg/mL)
4) Number of seropositive subjects for anti-pertussis (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).
A seropositive subject is defined as a subject whose antibody concentration/titre is ≥ to the assay cut-off.
5) Antibody concentrations for anti-D and anti-T.
Concentrations will be expressed as geometric mean con-centrations (GMCs) for the seroprotection cut-off.
6) Antibody titres for anti-polio types 1, 2 and 3.
Titres will be expressed as geometric mean titres (GMTs) for the seroprotection cut-off.
7) Antibody concentrations for anti-PRP.
Concentrations will be expressed as GMCs for the seropro-tection cut-off.
8) Antibody concentrations for anti-PT, anti-FHA and anti-PRN.
Concentrations will be expressed as GMCs for the seropositivity cut-off.
9) Number of subjects with solicited local and general symptoms.
Occurrence of solicited local/general symptoms after each primary vaccination dose and following the booster vaccination.
10) Number of subjects with unsolicited adverse events (AEs).
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE.
11) Number of subjects with serious adverse events (SAEs).
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, or results in disabil-ity/incapacity.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) At Month 16
2) At Month 16
3) At Month 16
4) At Month 16
5) At Months 4 and 16
6) At Months 4 and 16
7) At Months 4 and 16
8) At Months 4 and 16
9) During the 4-day (Days 0-3) follow-up period after each dose
10) During the 31-day (Days 0-30) follow-up period after each dose
11) From Month 0 |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| 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
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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