Immunogenicity and safety study of GSK Biologicals' meningococcal conjugate vaccine (GSK 134612) when co-administered with routine vaccines in healthy infants and toddlers

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2013-002537-37-Outside-EU/EEA
• Date of registration: 23/07/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Immunogenicity and safety study of GSK Biologicals' meningococcal conjugate vaccine (GSK 134612) when co-administered with routine vaccines in healthy infants and toddlers
• Scientific title: A phase IIIb, open, multi-country, controlled, randomized study to demonstrate the immunogenicity and safety of GSK Biologicals' meningococcal conjugate vaccine, MenACWY-TT (GSK 134612) in healthy infants, given on a 3+1 primary and booster (2, 4, 6 and 15-18 months of age), a 1+1 primary and booster (6 and 15-18 months of age) or as a single dose at 15-18 months of age - MENACWY-TT-087
• Target sample size: 753
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002537-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different number of doses (1, 2 or 4) of the same product Number of treatment arms in the trial: 3

Countries of recruitment

Lebanon, Mexico

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 753
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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, intake of prednisone up to 0.5mg/kg/day, or equivalent is allowed. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine, and seasonal or pandemic influenza vaccine. Subjects may receive these vaccines anytime during the study according to the national recommendations and the Summary of Product Characteristics. BCG vaccination may be given any time up to Visit 1 (first vaccination visit) of the study.
•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 (pharmaceutical product or device).
•Previous vaccination against diphtheria, tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumoniae.
•History of receipt of meningococcal vaccine.
•Subjects who received a birth dose of Hepatitis B vaccine within the 30 days before the administration of the first study vaccine.
•History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease
•Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 vaccines.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures (history of a single, simple febrile seizure is permitted).
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.


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

Health Condition(s) or Problem(s) studied

Active immunisation of healthy infants to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y

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

Intervention(s)

Product Name: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Current Sponsor code: MenA-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenC-TT
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenW-135-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenY-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Synflorix
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 Pro

Primary Outcome(s)

Secondary Objective: •Immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y:
-one month post-dose 3, prior to and one month after the booster dose in group ACWY3+1;
-one month after one dose and prior to and one month after the booster dose in group ACWY1+1;
-prior to and one month after one dose of the vaccine in group ACWY1
•Immunogenicity of the MenACWY-TT conjugate vaccine in terms of vaccine response to MenACWY-TT one month after the booster dose (group ACWY3+1 and ACWY1+1) or the vaccine dose (ACWY1)
•Immunogenicity of the routine study vaccines with or without MenACWY-TT co-administration in all three groups
•Immunogenicity in terms of anti-tetanus one month after the booster dose (group ACWY3+1) or the vaccine dose (group ACWY1) of MenACWY-TT co-administered with routine vaccines
•Safety and reactogenicity of the study vaccines throughout the study period

Primary end point(s): Immunogenicity with respect to components of the investigational vaccine:
•Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titre = 1:8 in all subjects of group ACWY3+1.

Timepoint(s) of evaluation of this end point: 1 month after the administration of dose 3 of MenACWY-TT in the ACWY3+1 group (Visit 4).

Main Objective: To demonstrate the immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y one month post-dose 3 of MenACWY-TT at 7 months of age in healthy infants.
Criteria for immunogenicity:
For each serogroup, one month after dose 3 of MenACWY-TT vaccination, the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre = 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. ACWY3+1 group: one month post-dose 3, prior to the booster dose and 1 month post-booster dose
ACWY1+1 group: one month post-primary dose, prior to and one month after booster dose
ACWY1 group: pre- and post-vaccination
2. 1 month post-dose 3, prior to and 1 month post-booster dose
3. Within 8 days (Day 0-Day 7) after each vaccine dose
4. Within 31 days (Day 0-Day 30) after each vaccine dose
5. Throughout the study period
6. Throughout the study period

Secondary end point(s): 1. Immunogenicity with respect to component of the investigational vaccine (on secondary read-outs).
2. Immunogenicity with respect to components of the co- administered study vaccines (pneumococcal vaccine and DTPa-IPV/HIB) in all groups
3. Solicited local and general symptoms: occurrence of each solicited local and general symptoms
4. Unsolicited adverse events (AEs): occurrence of unsolicited AEs
5. Serious adverse event (SAEs): occurrence of SAEs
6. Occurrence of new onset of chronic illnesses (NOCIs): occur-rence of NOCIs (e.g. asthma, autoimmune disorders, type 1 diabetes, allergies)

Secondary ID(s)

114858

Source(s) of Monetary Support

GlaxoSmithKline Biologicals