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. |
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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 demonstrate that 2 doses of Vaxem Hib given to children on study is non-inferior to a comparator vaccine HIBERIX®.
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|
E.2.2 | Secondary objectives of the trial |
To compare the percentage of subjects with anti-PRP antibody levels ≥ 1.0 µg/mL one month after the second (last) vaccination between the two vaccines groups; Vaxem Hib and HIBERIX®. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy infants 180-364 days of age inclusive.
- Written informed consent obtained from parent/legal guardian after the nature of the study has been explained according to local regulatory requirements.
- Infants in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Infants who will be available for all scheduled visits (i.e. not planning to leave the area before the end of the study period). |
|
E.4 | Principal exclusion criteria |
- Parent or legal guardian is unwilling or unable to give written informed consent to participate in study.
- Subjects who will be unavailable for the duration of the study period.
- Infants who have received any other Haemophilus influenzae type b immunization dose prior to study start.
- Infants who presented a previous disease potentially related to Haemophilus influenzae type b.
- Children who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus irifluenzae type b disease.
- Premature (before 37 week of gestation) or birth weight less than 2500 g.
- History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component.
- Fever >38 °C (axillary) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the previous 7 days before enrollment.
- Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease.
- Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder.
- Subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder.
- Subjects with a clinically significant genetic anomaly.
- Treatment with corticosteroids or other immunosuppressive drugs.
- Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
- Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
- Simultaneous participation in any other investigational trial.
- Planned surgery during the study period.
- Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Proportion of subjects with anti-PRP responses > 0.15 µg/mL approximately one month after the last vaccination. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
one month after the last vaccination |
|
E.5.2 | Secondary end point(s) |
2. Proportion of subjects with anti-PRP responses > 0.1 µg/mL approximately one month after the last vaccination.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
one month after the last vaccination |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 |
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 |
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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.8.9.2 | In all countries concerned by the trial months | 2 |