| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers [Primary and booster immunization of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)] |
|
| E.1.1.1 | Medical condition in easily understood language |
Diphtheria
Tetanus
Whooping cough
Infection of the liver
Invasive bacterial disease such as Meningitis or Pneumonia
Polio |
|
| 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 | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054187 |
| E.1.2 | Term | Polio immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069533 |
| E.1.2 | Term | Haemophilus influenzae type b immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10069593 |
| E.1.2 | Term | Pertussis immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054181 |
| E.1.2 | Term | Hepatitis B immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054180 |
| E.1.2 | Term | Diphtheria immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054183 |
| E.1.2 | Term | Tetanus immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| 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 the Hib response in DTPa-HBV-IPV/Hib investigational group is non-inferior to DTaP5-HBV-IPV-Hib comparator group, 1-month post-booster vaccination in terms of geometric mean concentrations (GMCs) and percentage of subjects with anti-polyribosylribitol phosphate (PRP) antibody concentrations equal to or above (≥) 5 microgram per milliliter (μg/mL).
To demonstrate that the Hib response in DTPa-HBV-IPV/Hib investigational group is superior to DTaP5-HBV-IPV-Hib comparator group, 1-month post-booster vaccination in terms of GMCs and percentage of subjects with anti-PRP antibody concentrations ≥ 5 μg/mL. |
|
| E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity of Hib-components in terms of percentage of subjects above the thresholds for short-term (0.15 μg/mL) and long-term (1.0 μg/mL) protection as well as in terms of GMCs (post-primary, pre- and post-booster vaccination).
To assess the safety of DTPa-HBV-IPV/Hib and DTaP5-HBV-IPV-Hib co-administered with pneumococcal 13-valent conjugate vaccine in terms of unsolicited adverse events (AEs) and serious adverse events (SAEs). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
-Subjects' parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits).
-Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
-A male or female child between and including 6 and 12 weeks of age (42 to 84 days) at the time of the first vaccination.
-Subject born after at least 37 weeks of gestation.
-Healthy subjects as established by the investigator based on medical history and the clinical examination before entering into the study. |
|
| E.4 | Principal exclusion criteria |
-Any clinical condition that, in the opinion of the investigator, might pose any risk to the subject due to participation in the study. As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.
-Known history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib diseases since birth.
-History of any reaction or hypersensitivity likely to be caused or exacerbated by any excipient or active component of the vaccine(s).
-Any confirmed or suspected immunosuppressive or immunodeficient condition, including malignancies, based on medical history and physical examination (no laboratory testing required).
-Family history of congenital or hereditary immunodeficiency.
-Major congenital defects, as assessed by the investigator.
-Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined via medical history including physical examination.
-Medical history of neurological disorder, including seizures.
-Previous vaccination for diphtheria, tetanus, pertussis, HBV, poliomyelitis, Hib diseases and previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine, with the exception of a birth dose of HBV vaccine, which may be given in accordance with local recommendations.
-Use of any investigational or nonregistered product (drug, vaccine, or medical device) other than the study vaccine(s) during the period starting 30 days before the first dose of study vaccine(s) (Day -29 to Day 1), or planned use 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(s) with the exception of administration of vaccines given as part of the national immunization schedule and as part of routine vaccination practice, e.g., rotavirus vaccine, that are allowed at any time during the study period. In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if necessary for that mass vaccination vaccine, provided this vaccine/product(s) is licensed and used according to its Product Information.
-Administration of long-acting immune-modifying drugs in the period starting 30 days before the first dose and at any time during the study period.
-Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
-Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.
-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 noninvestigational vaccine/product (drug or medical device).
-Child in care. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
-Anti-PRP antibody concentrations at Month 11, based on Per protocol set (PPS)
-Percentage of subjects with anti-PRP antibody concentrations equal to or above (≥) 5 μg/mL at Month 11, based on PPS
-Anti-PRP antibody concentrations at Month 11, based on the Exposed Set (ES)
-Percentage of subjects with anti-PRP antibody concentrations ≥ 5 μg/mL at Month 11, based on ES |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At Month 11 (i.e., 1-month post-booster vaccination) |
|
| E.5.2 | Secondary end point(s) |
-Percentage of subjects with anti-PRP antibody concentration ≥ 0.15 μg/mL
-Percentage of subjects with anti-PRP antibody concentrations ≥ 1.0 μg/mL
-Anti-PRP antibody concentrations
-Number of subjects with unsolicited adverse events (AEs)
-Number of subjects with serious adverse events (SAEs) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
-At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster), Month 11 (i.e., 1- month post-booster vaccination)
-During the 31-day (Days 1-31) follow-up period after each vaccination
-During the entire study period (i.e., Day 1 – Month 11)
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| 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 |
|
| 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) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| 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 | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 34 |
| 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 | Information not present in EudraCT |
| 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
|
| the release date of the last testing results of samples collected at Visit 5 |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| 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 | 6 |
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