E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Invasive Haemophilus influenzae type b disease |
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E.1.1.1 | Medical condition in easily understood language |
Invasive Haemophilus influenzae type b disease |
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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 |
Immunogenicity objective: To demonstrate that Vaxem Hib given to healthy infants aged 2 - 4 months at study entry is non-inferior to comparator vaccine HIBERIX (GlaxoSmithKline) with regard to percentage of subjects with antibody levels of ≥ 0.15 micrograms/mL one month after last vaccination dose as measured by anti-PRP ELISA.
Safety Objectives: 1. To compare safety and tolerability of three doses of Vaxem Hib (Novartis Vaccines) and control vaccine HIBERIX (GSK) when given to healthy infants aged 2 - 4 months.
2. To determine incidence/percentage of subjects with local and systemic adverse reactions, adverse events (AEs), and serious adverse events (SAEs) after each vaccination. |
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E.2.2 | Secondary objectives of the trial |
To evaluate percentage of subjects after primary immunization with Vaxem Hib(Novartis Vaccines) in comparison with HIBERIX (GSK) with regard to antibody levels of≥ 1.0 micrograms/mL one month after last vaccination as measured by anti-PRP ELISA (i.e., long term protection). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Infants of either sex, aged 2 - 4 months in good health as determined by:
1. Medical history
2. Physical examination
3. Clinical judgment of the investigator;
4. Available for all visits scheduled in the study and able to comply with all study regulations
5. For whom written informed consent has been obtained from at least one parent or legal guardian |
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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 have received any other Haemophilus influenzae type b immunization dose before
3. Infants who presented a previous disease potentially related to Haemophilus influenzae type b
4. Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
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) or/and 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. Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
14. Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects with the serum anti-PRP antibody titers ≥0.15 μg/mL. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The percentage of subjects with the serum anti-PRP antibody titers ≥1.0 μg/mL at one month after the third vaccination. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | 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? | Yes |
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 | 3 |