E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To assess the safety and tolerability of 3 doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age (i.e., combined DTaP-IPV-HBV-Hib vaccine and pneumococcal conjugate vaccine). |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018588 |
E.1.2 | Term | Gonococcal meningitis |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028910 |
E.1.2 | Term | Neisseria meningitides meningitis |
|
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 assess the immunogenicity of 3 doses of rMenB+OMV NZ (3 lots combined) given to healthy infants at 2, 4 and 6 months of age concomitantly with routine infant vaccines, by evaluation of the serum bactericidal activity (SBA), at 1 month after the third vaccination. - To show the consistency of immune response from 3 lots of rMenB+OMV NZ, by serum bactericidal activity geometric mean titer response (SBA GMTs), when administered to healthy infants at 2, 4 and 6 months of age, at 1 month after the third vaccination. |
|
E.2.2 | Secondary objectives of the trial |
- To assess the consistency of immune response from 3 lots of rMenB+OMV NZ, as measured by percentage of subjects with SBA titer ≥1:4 when administered to healthy infants at 2, 4 and 6 months of age, at 1 month after the third vaccination. - To demonstrate that the immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4 and 6 months of age, is non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. - To asses the prevalence of meningococcal B antibodies over the study period by evaluation of the serum bactericidal activity (SBA), at baseline and at 1 month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by medical history, physical examination and clinical judgment of the investigator. |
|
E.4 | Principal exclusion criteria |
1. History of any meningococcal B or C vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; 3. Previous ascertained or suspected disease caused by N. meningitidis; 4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. Significant acute or chronic infection within the previous 7 days or fever (defined as rectal temperature 38.5C) within the previous day; 7. Antibiotics within 6 days prior to enrollment; 8. Any serious chronic or progressive disease in the opinion of the investigator (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. Known or suspected impairment/alteration of the immune system, such as immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids since birth (e.g., 1 mg/kg/day of prednisone [or its equivalent]); budesonide 800 g per day or fluticasone 750 g per day). [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants; 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of Rotavirus vaccines), within 30 days prior and throughout the study period; 12. Participation in another clinical trial since birth or planned for during study; 13. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Bactericidal activity (% ³1:4 , i.e. percentage of subjects with SBA titer ³1:4) 30 days following the third vaccination (receiving either rMenB+OMV NZ (Lot 1, Lot 2 and Lot 3) .The immune response for the for the Norwegian strain H44/76 and New Zealand strain NZ98/254 will be sufficient if the lower limit of the 95% CI for the % ³1:4 for the three lots combined is ³70% and is ³50% for strain 5/99. If the immunogenicity response for the three strains for the three lots combined is sufficient then: - Immunogenicity of the 3 lots of rMenB+OMV NZ will be considered equivalent if, for each of the 3 strains and each pair of vaccine lots, the two-sided 95% CI on the ratio of GMTs at 1 mo3nth after the third vaccination is contained within the interval [0.50, 2.00]. |
|
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 | Yes |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |