E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. |
|
E.1.1.1 | Medical condition in easily understood language |
Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. |
|
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 determine safety and tolerability of Vaxem Hib when given to 20 healthy children aged 16 – 20 months and subsequently to 20 healthy infants aged 2 - 4 months. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Infants of either sex, aged 16 - 20 months / 2 - 4 months;
2) in good health as determined by:
• medical history
• physical examination
• clinical judgment of the investigator.
3) available for all visits scheduled in the study and able to comply with all study
regulations;
4) written informed consent obtained, from at least one parent or legal guardian;
Informed consent must be obtained for all the subjects before enrollment into the study |
|
E.4 | Principal exclusion criteria |
1) parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
2) infants who presented a previous disease potentially related to Haemophilus influenzae type b;
3) infants who had household contact and/or intimate exposure in the previous 30mdays to an individual with ascertained Haemophilus influenzae type b disease;
4) infants who have received any other Haemophilus influenzae type b immunizationmdose before (for 16-20 months old children who have received a booster vaccination already);
5) premature (before 37th week of gestation) or birth weight less than 2500 g;
6) history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
7) fever ≥38.0 °C (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
8) subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
9) known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
10) subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder;
11) subjects with a clinically significant genetic anomaly;
12) treatment with corticosteroids or other immunosuppressive drugs;
13) treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
14) any vaccination administered within 2 weeks (14 days) before enrollment;
15) participation in any other investigational trial simultaneously;
16) planned surgery during the study period;
17) any condition, which, in the opinion of the investigator, might interfere with the
evaluation of the study objective; |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of subjects with reported local and systemic reactions after each vacination.
2. Number of subjects with reported Serious adverse events (SAE) and/ or adverse events necessitating a physician's visit and/ or resulting in premature withdrawal from the study.
3. All adverse events are colllected throughout the study. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 1 to 7 days after each vaccination.
2. Days 0 to Day 30.
3. Throughout the study.
|
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
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) | 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 | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
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 | 0 |