| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| 1-dose vaccination of healthy toddlers between 12-23 months of age at the time of vaccination against Streptococcus pneumoniae (S. pn) and Haemophilus influenzae (Hi) who previously received 3 doses of Synflorix. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Vaccination against pneumococcal and Haemophilus influenzae diseases of healthy children aged less than 2 years. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018953 |
| E.1.2 | Term | Haemophilus influenzae meningitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042194 |
| E.1.2 | Term | Streptococcus pneumoniae meningitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042196 |
| E.1.2 | Term | Streptococcus pneumoniae secondary bacterial infection of acute bronchitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018954 |
| E.1.2 | Term | Haemophilus influenzae secondary bacterial infection of acute bronchitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018952 |
| E.1.2 | Term | Haemophilus influenzae infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10035680 |
| E.1.2 | Term | Pneumonia due to Haemophilus influenzae (H. influenzae) |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054642 |
| E.1.2 | Term | Streptococcus pneumoniae septicemia |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042195 |
| E.1.2 | Term | Streptococcus pneumoniae pneumonia |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10058214 |
| E.1.2 | Term | Septicaemia due to haemophilus influenzae (H. influenzae) |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042197 |
| E.1.2 | Term | Streptococcus pneumoniae septicaemia |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 safety and reactogenicity of 1 dose of 2830930A vaccine administered to toddlers aged 12-23 months primed with 3 doses of Synflorix, in terms of occurrence of grade 3 related solicited and unsolicited adverse events and related serious adverse events. |
|
| E.2.2 | Secondary objectives of the trial |
• To evaluate the safety and reactogenicity of 1 dose of 2830930A vaccine when administered to toddlers aged 12-23 months primed with 3 doses of Synflorix, in terms of occurrence of any adverse events including SAEs.
• To assess the immune response elicited by 1 dose of 2830930A vaccine when administered to toddlers aged 12-23 months primed with 3 doses of Synflorix. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
All subjects must satisfy ALL the following criteria at study entry:
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
• A male or female between, and including 12 to 23 months of age at the time of vaccination
• Written informed consent obtained from the parents/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of at least 36 weeks.
• Previously completed three-dose vaccination course with Synflorix. |
|
| E.4 | Principal exclusion criteria |
• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines
- The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
• 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 product
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
• History of any neurological disorders or seizures, including conditions such as hypotonic-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
• Acute disease and/or fever at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
• Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
• Previous receipt of a booster dose (fourth dose) of Synflorix.
• Anaphylaxis following previous administration of vaccines. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
• Occurrence of each grade 3 solicited adverse event with relationship to vaccination
• Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
• Occurrence of serious adverse events with relationship to vaccination |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Within 7 days (Day 0-Day 6) after vaccination
• Within 31 days (Day 0-Day 30) after vaccination
• Throughout the entire study (from Month 0 up to Month 1) |
|
| E.5.2 | Secondary end point(s) |
• Occurrence of each solicited adverse event
- Solicited local adverse events: any
- Solicited general adverse events: any and related
• Occurrence of any unsolicited adverse event
• Occurrence of any serious adverse event
• Evaluation of the immune responses to the components of the 2830930A vaccine
- Concentrations of antibodies and opsonophagocytic activity against all the components of the investigational pneumococcal vaccine |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Within 7 days (Day 0-Day 6) after vaccination
• Within 31 days (Day 0-Day 30) after vaccination
• Throughout the entire study (from Month 0 up to Month 1)
• One month post-vaccination |
|
| 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) | Yes |
| E.7.1.1 | First administration to humans | Yes |
| 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) | 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 | Yes |
| 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 |
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 | 6 |
| 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 | Yes |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
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