E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b. |
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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 immunogenicty of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of response to all vaccine antigens.
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E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity of the DTPa-HBV-IPV/Hib vaccine in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with DTPa-HBV-IPV/Hib vaccine, in terms of response to all vaccine antigens. To assess the reactogenicity and safety of the DTPa-HBV-IPV/Hib vaccine given as a booster after primary vaccination with either DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing) or with DTPa-HBV-IPV/Hib vaccine for the primary vaccination course.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study DTPa-HBV-IPV-116 (106786). A male or female between, and including, 16 and 20 months of age at the time of booster vaccination. Written informed consent obtained from the parent or guardian of the subject Healthy subjects as established by medical history and clinical examination before entering into the study.
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed). Participation in another clinical study, between the primary study DTPa-HBV-IPV-116 (106786) and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose. Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study DTPa-HBV-IPV-116. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required). History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5°C. Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. Absolute contraindications One of the following adverse events having occurred after previous administration of DTP vaccine Hypersensitivity reaction due to the vaccine. Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination 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. Warnings and precautions Fever ≥ 40.5°C rectal temperature within 48 hours of vaccination. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours Convulsions with or without fever, occurring within 3 days of vaccination.
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E.5 End points |
E.5.1 | Primary end point(s) |
For the DSSITGDPa-HBV-IPV/Hib groups (preservative-free or preservative containing): Immunogenicity before and one month after the booster vaccination • Seroprotection status: Anti-diphtheria* and anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml Anti-HBs antibody concentrations greater than or equal to 10 mIU/ml and greater than or equal to100 mIU/ml Anti-poliovirus type 1, type 2 & type 3 antibody titres greater than or equal to8 Anti-PRP antibody concentrations greater than or equal to 0.15µg/ml and greater than or equal to 1.0 µg/ml * Sera negative for anti-diphtheria antibodies by ELISA will be retested with the more sensitive in vitro Vero-cell assay. • Seropositivity status: Anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to 5 El.U/ml • Anti-diphtheria and anti-tetanus toxoids, anti-PT, anti-FHA, anti-PRN, anti-HBs, anti-poliovirus type 1, type 2 & type 3 and anti-PRP antibody concentrations or titres. Immunogenicity one month after the booster vaccination • Vaccine response to PT, FHA and PRN defined as appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations greater than or equal to cut-off value).
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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 | 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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | 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
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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 | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 1 |