Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.

• Register: EUCTR
• Last refreshed on: 8 May 2012
• Main ID: EUCTR2011-002225-22-DE
• Date of registration: 22/08/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.
• Scientific title: A phase I, randomized, controlled, double-blind study to assess safety, reactogenicity and immunogenicity of GSK Biologicals’ pneumococcal vaccine 2830930A when administered as a single dose in healthy toddlers aged 12-23 months. - SPNG-007
• Date of first enrolment: 29/11/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002225-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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:
• 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10042196 Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10018954 Term: Haemophilus influenzae secondary bacterial infection of acute bronchitis System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10035680 Term: Pneumonia due to Haemophilus influenzae (H. influenzae) System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10054642 Term: Streptococcus pneumoniae septicemia System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10058214 Term: Septicaemia due to haemophilus influenzae (H. influenzae) System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Synflorix
Product Name: Synflorix
Pharmaceutical Form: Suspension for injection
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJ. PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUENZAE DERIVED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJ. TO TETANUS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJ. TO DIPHTHERIA TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23 F CONJ. TO PROTEIN D (NON-TYPEABLE H. INFLUEN

Primary Outcome(s)

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)

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

Secondary Outcome(s)

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

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

Secondary ID(s)

115373

Source(s) of Monetary Support

GSK Biologicals