A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-008104-41-CZ
• Date of registration: 07/04/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014
• Scientific title: A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014
• Date of first enrolment: 03/07/2009
• Target sample size: 690
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008104-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Czech Republic

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, 31 and 44 months of age at the time of the enrolment.
Subjects who previously participated in study 10PN-PD-DIT-014 (107137):
*For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the 10PN-PD-DIT-014 study amendment 3.
*For the subjects in the unprimed group: subjects who received a dose of the MenACWY-TT vaccine.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

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 within 30 days preceding enrolment, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
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).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-014 (107137).


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

Health Condition(s) or Problem(s) studied

Subjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137).

Intervention(s)

Product Name: 10-valent pneumococcal conjugate vaccine
Product Code: 10Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PS-PD for serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F; PS-TT for serotype 18C; PS-DT for serotype 19F.
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS: 32; PD: 26-TT: 16 ; DT:10

Primary Outcome(s)

Main Objective: •To demonstrate the immunological memory induced following primary vaccination in study 10PN-PD-DIT-010 (107017) and booster vaccination in study 10PN-PD-DIT-014 (107137) with the 10Pn-PD-DiT vaccine, through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, compared to the unprimed group.
Criteria for immune memory:
The immune memory will be demonstrated if the lower limit of the 95% CI around the GMC ratios (pooled primed groups over unprimed group) is higher than 1 for all 10 vaccine serotypes.

Primary end point(s): Demonstration of immune responses to components of the investigational vaccine, 7-10 days after the single/first dose of investigational vaccine:
*Concentrations of antibodies against vaccine pneumococcal serotypes.

Secondary Objective: Antibody persistence 25-36 months after the last 10Pn-PD-DiT vaccine dose administered at 12-15 months of age in study 107137
Long-term effects of the 10Pn-PD-DiT vaccine on nasopharyngeal carriage 16-32 months and 25-36 months following the last vaccine dose administered at 12-15 months of age in study 107137
Antibody persistence 25-36 months after vaccination with MenACWY-TT conjugate vaccine in study 107137
Immunogenicity of 10Pn-PD-DiT vaccine when given as a 2-dose catch-up vaccination course to the unprimed children that participated in study 107137 in their fourth year of life
Safety/reactogenicity of 10Pn-PD-DiT vaccine when given as a 2-dose catch-up vaccination course to the unprimed children that participated in study 107137 in their fourth year of life
Safety/reactogenicity of an additional booster dose of 10Pn-PD-DiT vaccine administered at 40-48 months of age in children previously vaccinated with 10Pn-PD-DiT vaccine at 12-15 months of age in study 107137

Secondary ID(s)

112801