An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-001823-39-SE
• Date of registration: 27/09/2004
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010
• Scientific title: An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010
• Date of first enrolment: 15/11/2004
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001823-39
• 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: yes Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of enrollment.
Written informed consent obtained from the parents or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period between 36 and 42 weeks.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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:
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.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease and/or S. pneumoniae.
History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, meningococcal serogroup C disease and/or invasive pneumococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment: study entry should be postponed until the illness has improved. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Study vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 37.5°C / axillary temperature < 37.5°C / rectal temperature < 38°C).
Other conditions that in the opinion of the investigator may potentially interfere with interpretation of study outcomes; these conditions must be recorded on a specific log sheet.




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

Health Condition(s) or Problem(s) studied

Prophylactic vaccination against pneumococcal diseases in infants and diseases caused by Neisseria meningitidis C.

Intervention(s)

Product Name: 11-valent Streptococcus pneumoniae conjugate vaccine
Product Code: 11Pn-PD-DiT
Pharmaceutical Form: Suspension for injection

Product Name: Combined Haemophilus influenzae type B and Neisseria meningitidis serogroup C conjugate vaccine
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder and solvent for suspension for injection

Trade Name: Infanrix hexa
Product Name: Infanrix hexa
Product Code: DTPa-HBV-IPV/Hib
Pharmaceutical Form: Powder and solvent for suspension for injection

Trade Name: Infanrix penta
Product Name: Infanrix penta
Product Code: DTPa-HBV-IPV
Pharmaceutical Form: Suspension for injection

Trade Name: Prevenar
Product Name: Pneumoccocal saccharide conjugated vaccine, adsorbed
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

Secondary Objective: The immune response post-dose 2 elicited by 11Pn-PD-DiT administered according to a 3,5,12 month vaccination schedule with co-administration of Infanrix™ hexa
Safety and reactogenicity of 11Pn-PD-DiT administered according to a 3,5,12 month vaccination schedule as part of a staggered vaccination schedule with co-administration of Infanrix™ penta and HibMenC-TT at 2,4 months
Safety, reactogenicity and immune response to HibMenC-TT when co-administered with Infanrix ™ penta at 2,4 months and when co-administered with 11Pn-PD-DiT at 12 months and as part of a staggered vaccination schedule with 11Pn-PD-DiT Persistence of pneumococcal antibodies elicited by 11Pn-PD-DiT prior to booster vaccination at 12 months
Immune response elicited by a booster of 11Pn-PD-DiT following two doses at 3,5 months when co-administered with HibMenC-TT or Infanrix™ hexa at 12 months
Immune response elicited by Infanrix™ hexa or Infanrix™ penta when co-administered with 11Pn-PD-DiT or HibMenC-TT

Main Objective: To assess the immune response post-dose 2 elicited by GSK Biologicals’ candidate 11Pn-PD-DiT vaccine administered according to a 3, 5, 12 month vaccination schedule as part of a staggered vaccination schedule with co-administration of Infanrix™ penta and GSK Biologicals’ candidate HibMenC-TT vaccine at 2, 4 months of age.

Primary end point(s): In all subjects, 1 month after dose 2 of 11Pn-PD-DiT or Prevenar®:
-antibody concentrations to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Secondary ID(s)

103502