E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is looking at the vaccine responses of premature infants to the Men B vaccine. |
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E.1.1.1 | Medical condition in easily understood language |
This study is looking at the vaccine responses of premature infants to the Men B vaccine. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 compare the immune responses of infants born prematurely to Men B vaccination after two primary doses at 2 and 4 months of age compared with three primary doses at 2, 3 and 4 months of age. |
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E.2.2 | Secondary objectives of the trial |
-To describe the reactions seen following routine vaccines (including Men B vaccine) in premature infants; -To compare the persistence of immunological responses to MenB vaccine at 12 months of age after two doses at 2 and 4 months of age with three doses at 2, 3 and 4 months of age; -To compare the immunological responses following the 12 month booster of Men B vaccine in babies who received two doses at 2 and 4 months of age with those who received three doses at 2, 3 and 4 months of age.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Premature infant born at <35 weeks gestation No contraindications to vaccination according to the ‘Green Book’ Willing and able to comply with study procedures Written informed consent |
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E.4 | Principal exclusion criteria |
Contraindication to vaccination according to the Green Book Life-limiting congenital abnormality or condition Prior diagnosis of an immunodeficiency syndrome Considered unlikely to complete expected follow up until the end of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
(i)hSBA GMTs one month after completing primary immunisations for relevant 4CMenB antigens: fHbp, NadA and PorA (ii)hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB antigens: fHbp, NadA and PorA
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This will be assessed in infants one month after the completion of the primary immunisations. |
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E.5.2 | Secondary end point(s) |
(i)The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose; (ii)The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 48 hours following each vaccine dose; (iii)The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination; (iv)hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB antigens: fHbp, NadA and PorA; (v)hSBA proportions ≥ 1:4, at 12 months of age (pre booster) for relevant 4CMenB antigens: fHbp, NadA and PorA; (vi)hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB antigens: fHbp, NadA and PorA; (vii)hSBA proportions≥1:4, at 13 months of age (post booster) for relevant 4CMenB antigens: fHbp, NadA and PorA.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(i) This will be assessed following each vaccination at 2,3,4 and 12 months (ii) This will be assessed following each vaccination at 2,3,4 and 12 months (iii) This will be assessed following each vaccination at 2,3,4 and 12 months (iv)This will be assessed at 12 months of age (v) This will be assessed at 12 months of age (vi) This will be assessed at 13 months of age (vii) This will be assessed at 13 months of age |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 8 |
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 | No |
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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last Blood samples processed, results analysed and report produced. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 1 |