| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers [Primary immunisation of infants 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
Lock jaw
Whopping cough
Hepatitis B
Polio
Influenza
|
|
| 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 | LLT |
| E.1.2 | Classification code | 10006025 |
| E.1.2 | Term | Bordetella pertussis laryngotracheobronchitis |
| E.1.2 | System Organ Class | 100000004862 |
|
| 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 immunological response to DTPa-HBV-IPV/Hib in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and Hib antigens, and in terms of vaccine response to the pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery. |
|
| E.2.2 | Secondary objectives of the trial |
•To assess persistence of antibodies against diphtheria, tetanus and pertussis antigens, before the first dose of DTPa-HBV-IPV/Hib in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
•To assess the immunological response to DTPa-HBV-IPV/Hib and 13Pn in terms of antibody concentrations or titres against all antigens, one month* after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
•To assess the immunological response to DTPa-HBV-IPV/Hib in terms of seropositivity rates against pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
•To assess the safety and reactogenicity of DTPa-HBV-IPV/Hib and 13Pn in terms of solicited and unsolicited symptoms 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. completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
•A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the first vaccinationat the time of the first vaccination.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
•Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of the investigator.
*Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
|
|
| E.4 | Principal exclusion criteria |
•Child in care
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean predni-sone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
•Administration of any chronic drug therapy to be continued during the study period.
•A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
*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 immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
•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 (pharmaceutical product or device).
•Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
•History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID), based on medical history and physical examination (no laboratory testing required).
•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/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or planned administration during the study period.
•Hypersensitivity to latex.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity with respect to components of DTPa-HBV-IPV/Hib.
- Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol phosphate (anti-PRP) seroprotection status.
- Vaccine response to PT, FHA and PRN antigens. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Month 3 or Month 5 (depending on vaccination schedule of the country). |
|
| E.5.2 | Secondary end point(s) |
Persistence of antibodies before the first dose of DTPa-HBV-IPV/Hib- Anti-diphtheria and anti-tetanus seroprotection status, anti-PT, anti-FHA, anti-PRN seropositivity status and antibody concentrations.
Immunogenicity with respect to components of DTPa-HBV-IPV/Hib and 13Pn - Anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs, anti-PRP, anti-PT, anti-FHA, anti-PRN and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibody concentrations or titres.
Immunogenicity with respect to components of DTPa-HBV-IPV/Hib-Anti-PT, anti-FHA, anti-PRN antibody seropositivity status.
Occurrence of solicited local/general symptoms.
Occurrence of unsolicited symptoms.
Occurrence of serious adverse events. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Persistence of antibodies before the first dose of DTPa-HBV-IPV/Hib- Month 0.
Immunogenicity with respect to components of DTPa-HBV-IPV/Hib and 13Pn - Month 3 or Month 5 (depending on vaccination schedule of the country).
Immunogenicity with respect to components of DTPa-HBV-IPV/Hib- Month 3 or Month 5 (depending on vaccination schedule of the country) .
Occurrence of solicited local/general symptoms- During 4 day (Day 0-Day 3) after each dose of study vaccines.
Occurrence of unsolicited symptoms- During the 31-day (Day 0-Day 30) follow-up period after each dose of study vaccines.
Occurrence of serious adverse events- From Month 0 up to Month 3 or Month 5 (depending on vaccination schedule of the country). |
|
| 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 |
|
| 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 | 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 | 2 |
| 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 | No |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
| Australia |
| Canada |
| Czech Republic |
| Finland |
| Italy |
| Spain |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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 testing results released of samples collected at Visit 4. |
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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 | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 21 |
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