E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active immunization against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the brain and infection of the blood |
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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 |
•To evaluate the immunogenicity of MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
*Vaccine response to meningococcal antigens (A, C, W-135 and Y) is defined as:
- For initially seronegative subjects (pre-vaccination rSBA titer below 1:8): rSBA antibody titer ≥ 1:32 one month after vaccination, and
- For initially seropositive subjects (pre-vaccination rSBA titer ≥ 1:8): at least four-fold increase in rSBA titers from pre-vaccination to one month after vaccination.
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E.2.2 | Secondary objectives of the trial |
One month post booster vaccination with MenACWY-TT vaccine:
•To evaluate the immunogenicity of a booster dose of MenACWY-TT conjugate vaccine with respect to the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers ≥ 1:8, ≥ 1:128 and GMTs.
•To evaluate the percentage of subjects with anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and GMCs.
Long-term persistence phase: two and four years after MenACWY-TT booster vaccination:
•To evaluate the long-term antibody persistence induced by MenACWY-TT conjugate vaccine in terms of the percent-age of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8, ≥1:128 and GMTs.
One month post booster vaccination with MenACWY-TT vaccine:
•To evaluate the safety and reactogenicity of a booster dose of MenACWY-TT conjugate vaccine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
•A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
•Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
•Having completed the vaccination in study HIB-MENC-TT-016 (106445) as per protocol. |
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E.4 | Principal exclusion criteria |
•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
•Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
•Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the HIB-MENC-TT-016 study.
•History of meningococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
•Acute disease and/or fever at the time of enrollment.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e., between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3 and Visit 4.
The following criteria should be checked for the long-term persistence phase at two and four years after booster vaccination (Visit 3 and Visit 4):
•Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in HIB-MENC-TT-016 and the booster vaccination in this particular study.
•History of meningococcal disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity with respect to the components of the investigational vaccine with MenACWY-TT vaccine (primary readouts):
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month after booster vaccination |
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E.5.2 | Secondary end point(s) |
1. Immunogenicity with respect to the components of the Men-ACWY-TT vaccine (secondary readouts):
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:8, ≥1:128 and GMTs.
•Anti-TT concentrations ≥0.1 IU/mL, ≥1.0 IU/mL and GMCs.
2. Long-term persistence phase: Immunogenicity with respect to the components of the MenACWY-TT vaccine (secondary readouts)
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:8, ≥1:128 and GMTs
3. Occurrence of solicited local and general symptoms
4. Occurrence of unsolicited adverse events, serious adverse events (SAEs), Guillain-Barré syndrome and new onset of chronic illness(es) (NOCIs)
5. Occurrence of SAEs related to MenACWY-TT booster vaccination or related to study participation or concurrent GSK medication/vaccine or any fatal SAE |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 1 month after booster vaccination
2. 2 and 4 years after booster vaccination
3. Within 4 days (Day 0 to Day 3) following booster vaccination
4. Within 31 days (Day 0 to Day 30) following booster vaccination
5. Through the entire study period (Day 0 to study end) |
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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 | No |
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 | No |
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 | No |
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
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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 years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 1 |