Impact of GSK Biologicals’ 2189242A vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 yrs in The Gambia.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-002727-15-Outside-EU/EEA
• Date of registration: 22/06/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Impact of GSK Biologicals’ 2189242A vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 yrs in The Gambia.
• Scientific title: A phase II, randomized, controlled, observer-blind study to evaluate the impact of two formulations of GlaxoSmithKline (GSK) Biologicals’ combined 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate and pneumococcal protein vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 years in The Gambia. - SPNG-005
• Target sample size: 1320
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002727-15
• 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: yes Other trial design description: Stepwise enrolment If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 8

Countries of recruitment

Gambia

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Male or female between, and including,
- 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
- 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
• Signed or thumb-printed 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.
• Permanent residence in the study area and no intention of leaving during the study period.
Additional inclusion criteria for subjects in Cohort 1:
• Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1320
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 for subjects in Cohort 1 (children) and Cohort 2 (infants):
• 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 within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines or other vaccines recommended as part of a national campaign (e.g. Polio, Measles or Meningococcal 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
• Previous vaccination against S. pneumoniae.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Malnutrition
• A 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 any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Contraindications to any co-administered vaccine.
• Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Additional exclusion criteria for subjects in Cohort 2:
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).


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

Health Condition(s) or Problem(s) studied

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

Healthy volunteers (for one-dose vaccination of healthy children between 2-4 years of age at the time of vaccination against Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. influenzae) and three-dose vaccination of healthy infants between 8-10 weeks (56-76 days) of age at the time of the first vaccination, against S. pneumoniae and H. influenzae according to either a 2-3-4 months of age schedule or a 2-4-9 months of age schedule)
MedDRA version: 18.0 Level: LLT Classification code 10042196 Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10018954 Term: Haemophilus influenzae secondary bacterial infection of acute bronchitis System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10042194 Term: Streptococcus pneumoniae meningitis System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10054642 Term: Streptococcus pneumoniae septicemia System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10018953 Term: Haemophilus influenzae meningitis System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10058214 Term: Septicaemia due to Haemophilus influenzae (H. influenzae) System Organ Class: 100000004862
MedDRA version: 18.0 Level: LLT Classification code 10035680 Term: Pneumonia due to Haemophilus influenzae (H. influenzae) System Organ Class: 100000004862

Intervention(s)

Product Code: 10Pn-PD-DiT-dPly-PhtD 10
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL PO

Primary Outcome(s)

Main Objective: • To assess the safety and reactogenicity of GSK Biologicals’ combined 10Pn-PD-DiT and pneumococcal protein vaccine (10Pn-PD-DiT-dPly-PhtD) when administered as a one-dose schedule to children aged 2-4 years, in terms of occurrence of grade 3 related solicited and unsolicited adverse events and related serious adverse events (Cohort 1)
• To assess the impact of 10Pn-PD-DiT-dPly-PhtD on nasopharyngeal carriage of non-vaccine S. pneumoniae serotypes when co-administered with routine EPI vaccines as a 3-dose vaccination course (Cohort 2).

Secondary Objective: • Immune response, safety and reactogenicity of 10Pn-PD-DiT-dPly-PhtD in children aged 2-4 years (Cohort 1)
• Compare protein doses in 10Pn-PD-DiT-dPly-PhtD given as 3-dose primary vaccination to infants and co-administered with DTPw-HBV/Hib and OPV (Cohort 2)
• Safety and reactogenicity of 10Pn-PD-DiT-dPly-PhtD co-administered with routine EPI vaccines as 3-dose vaccination (Cohort 2)
• Immune responses to 10Pn-PD-DiT-dPly-PhtD co-administered with routine EPI vaccines as 3-dose vaccination (Cohort 2)
• Impact of 10Pn-PD-DiT-dPly-PhtD on nasopharyngeal carriage of vaccine/cross-reactive S. pneumoniae serotypes, H. influenzae and other bacterial pathogens when co-administered with routine EPI vaccines as 3-dose vaccination (Cohort 2)
• Safety and immune response to DTPw-HBV/Hib and OPV co-administered with 10Pn-PD-DiT-dPly-PhtD as 3-dose vaccination (Cohort 2)
• Safety and immune response to measles and yellow fever vaccines co-administered with 10Pn-PD-DiT-dPly-PhtD (Cohort 2)

Timepoint(s) of evaluation of this end point: • Within 4 days (Day 0-Day 3) after vaccination
• Within 31 days (Day 0-Day 30) after vaccination
• From Day 0 to last study visit
• One (Month 3), five (Month 7) and eight (Month 10) months after dose 3 for the 3+0 schedule groups and one (Month 3), five months (Month 7) after dose 2 and three (Month 10) months after dose 3 for the 2+1 schedule groups.

Primary end point(s): • Occurrence of each grade 3 solicited local and general adverse event with relationship to vaccination (Cohort 1)
• Occurrence of grade 3 unsolicited adverse events with relationship to vaccination (Cohort 1)
• Occurrence of serious adverse events (SAEs) with relationship to vaccination (Cohort 1)
• Occurrence of non-vaccine serotypes of S. pneumoniae in the nasopharynx (Cohort 2)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: • Within 4 days (Day 0-Day 3) after each vaccination
• Within 31 days (Day 0-Day 30) after each vaccination
• From Day 0 to Day 30 and up to the end of the extended 6 months safety follow-up
• From Day 0 to last study visit
• Day 0 and one month after vaccination (Month [M] 1)
• One month after vaccination (M1)
• One, 5 and 8 months after dose 3 (M3, 7 and 10) for the 3+0 schedule groups and one, 5 months after dose 2 (M3 and 7) and 3 months after dose 3 (M10) for the 2+1 schedule groups
• One month after dose 3 of the DTPw-HBV/Hib and OPV vaccines (M3)
• Three months after vaccination (M10)
• One, 5 and 8 months after dose 3 (M3, 7 and 10) for the 3+0 schedule groups and one, 5 months after dose 2 (M3 and 7) and 3 months after dose 3 (M10) for the 2+1 schedule groups

Secondary end point(s): • Occurrence of each solicited local and general adverse event (Cohort 1 and 2)
• Occurrence of any unsolicited adverse event (Cohort 1 and 2)
• Occurrence of any SAEs (Cohort 1)
• Occurrence of any SAEs (Cohort 2)
• Occurrence of any specified haematological or biochemical abnormalities (Cohort 1)
• Evaluation of the immune responses to the components of the investigational vaccine (Cohort 1)
• Evaluation of the immune responses to the components of the investigational vaccine (Cohort 2)
• Evaluation of the immune responses to components of the co-administered DTPw-HBV/Hib vaccine and OPV vaccines (Cohort 2)
• Evaluation of the immune responses to components of the co-administered measles and yellow fever vaccines (Cohort 2)
• Occurrence of S. pneumoniae, H. influenzae and other bacterial pathogens in the nasopharynx (Cohort 2)

Secondary ID(s)

114174

NCT01262872

Source(s) of Monetary Support

GlaxoSmithKline Biologicals