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 a Vaxem™ Hib booster given to children aged 12–18 months is noninferior to the comparator vaccine HIBERIX®. Non-inferiority will be assessed as the percentage of subjects with anti-PRP antibody levels ≥ 1.0 μg/mL one month after booster vaccination (i.e. long-term seroprotection rate).
To compare safety and tolerability of the booster dose of Vaxem™ Hib with the control booster dose of HIBERIX® when given to toddlers aged 12-18 months. |
|
E.2.2 | Secondary objectives of the trial |
To further evaluate the percentage of subjects after booster immunization with Vaxem™ Hib in comparison with HIBERIX® with regard to anti-PRP antibody levels ≥ 0.15 μg/mL (i.e. standard protective level) one month after booster vaccination.
Also, to evaluate GMCs following booster vaccination by means of related descriptive statistics. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Toddlers 12-18 months of age who have previously participated in study M37P2.
Children's parents or legal guardian have given written consent after the nature of the study has been
explained according to local regulatory requirements.
Toddlers in good health as determined by the outcome of medical history, physical examination and clinical
judgment of the investigator.
Availability for both visits scheduled in the study and able to comply with all study regulations. |
|
E.4 | Principal exclusion criteria |
Parent(s) or legal guardian(s) are unwilling or unable to give written informed consent to participate in
study.
Subjects who have already received a Hib booster dose.
History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or
hypersensitivity to any vaccine component.
Fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or
antiviral therapy within the past 7 days before enrollment.
Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or
neoplastic disease.
Known/suspected immunodeficiency or any immunologic disorder.
Subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder.
Subjects with a genetic anomaly.
Treatment with corticosteroids or other immunosuppressive drugs.
Previous receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
Vaccination with any other vaccine 14 days before or after the booster dose with Vaxem™ Hib .
Participation in any other investigational trial simultaneously.
Planned surgery during the study period.
Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study
objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving an anti-PRP concentration ≥ 1.0 μg/mL approximately one month post booster vaccination. The success criterion for the assessment of the primary objective is confirmation that the long-term seroprotection rate in the test subject (Vaxem™ Hib) study group is non-inferior as compared to the comparator group.
According to regulatory requirements, the non-inferiority margin is 5%-points, i.e. the study will claim this success if the lower two-sided 95% confidence limit for the underlying difference in proportions (in the Vaxem™ minus HIBERIX®) is greater than - Δ = -5%. (For details refer to the Statistical Methods section).
To determine incidence/percentage of subjects with local and/or systemic adverse reactions, adverse events (AEs), and serious adverse events (SAEs) after the booster in each group.
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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) |
1) Proportion of subjects achieving an anti-PRP concentration ≥ 0.15 μg/mL (point estimate as well as two-sided 95% confidence intervals).
2) Anti-PRP geometric mean concentration (GMC) (point estimate as well as two-sided 95% confidence intervals).
3)Percentiles (such as minimum, maximum or median) of antibody titers.
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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 |
|
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 | 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) | 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?
| No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |