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. MedDRA version: 14.0 Level: LLT Classification code 10018953 Term: Haemophilus influenzae meningitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis System Organ Class: 10
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.;Secondary Objective: • 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.;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;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed