| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib). |
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| E.1.1.1 | Medical condition in easily understood language |
Infanrix Hexa is a vaccine that protects people against infections like diphtheria, lock jaw, whopping cough, hepatitis B, polio and meningitis.
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| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| 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 Infanrix hexa in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and Hib antigens, and in terms of booster response for the pertussis antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery. |
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| E.2.2 | Secondary objectives of the trial |
1. To assess persistence of antibodies to all vaccine antigens before the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
2. To assess immunological response to Infanrix hexa and Prevenar 13 in terms of antibody concentrations against all antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
3. To assess immunological response to Infanrix hexa in terms of seropositivity rates against pertussis antigens, one month after the booster dose in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
4. To assess safety and reactogenicity of Infanrix hexa and Prevenar 13 in terms of solicited/unsolicited symptoms and SAEs.
5. To assess neurodevelopmental status of infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery, at 9 and 18 months of age. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Subjects’ parent(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 child 9 months of age at the time of enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and having completed their primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048 PRI].
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| E.4 | Principal exclusion criteria |
• Child in care
• Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ≥ 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).
• A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study 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 Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Major congenital defects.
• Serious chronic illness.
• Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period.
• Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
• History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI]
• Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients).
• Hypersensitivity to latex.
• History of any neurological disorders or seizures.
• Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Acute disease and/or fever at the time of vaccination.
- Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on 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. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Number of seroprotected subjects for anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-polyribosylribitol phosphate.
2. Number of subjects with a booster response to PT, FHA and PRN antigens. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. One month after the booster dose
2. One month after the booster dose |
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| E.5.2 | Secondary end point(s) |
1. Number of seroprotected subjects against anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-PRP.
2. Number of seropositive subjects Anti-PT, anti-FHA and anti-PRN and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
3. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-HBs and anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and anti-PRP antibody con-centrations or titres.
4. Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
5. Number of subjects with solicited local and general symptoms .
6. Number of subjects with unsolicited adverse events (AEs).
7. Number of subjects with serious adverse events (SAEs).
8. Neurodevelopmental status will be assessed at 9 and 18 months of age adjusted for prematurity. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. One month before booster dose
2. One month before booster dose
3. One month before and after booster dose
4. One month after booster dose
5. During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
6. During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
7. From booster dose up to study end
8. At 9 and 18 months of age |
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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 |
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| 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 | Information not present in EudraCT |
| 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 | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Australia |
| Canada |
| Czech Republic |
| Finland |
| Italy |
| Spain |
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| 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
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| Last testing results released of samples collected at Visit 3. |
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| 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 | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 7 |
| E.8.9.2 | In all countries concerned by the trial days | 24 |
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