A phase IIIa, open, multicentre study to evaluate the immunological memory induced in healthy children following a 3-dose primary vaccination with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or PrevenarTM in study 10PN-PD-DIT-003 (105554), via the administration of a single booster dose of a 23-valent pneumococcal plain polysaccharide vaccine. - 10PN-PD-DIT-008

• Conditions: A single dose of Sanofi Pasteur MSD’s unconjugated 23-valent polysaccharide pneumococcal vaccine (Pneumovax™23) to healthy children who were previously primed with the full three doses of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ in the primary vaccination study 10PN-PD-DIT-003.Children will be 11-14 months old at the time of enrolment in this study and will receive concomitantly their booster dose of Infanrix™hexa according to national recommendations.

• Registration Number: EUCTR2006-000560-93-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-04
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
• Male or female between, and including, 11-14 months of age at the time of vaccination.
• Subjects for whom 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).
• A male or female who previously participated in study 10PN-PD-DIT-003 and received the full three doses of pneumococcal conjugate 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

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
• 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 within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater or equal to 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 one month before the first dose of vaccine(s) and during the entire study period; with the exception of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) which may be administered concomitantly to Pneumovax™ 23 at 11-14 months of age.
• Administration of any pneumococcal vaccine other than the study vaccines from study 10PN-PD-DIT-003.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• Anaphylactic reaction following the administration of the vaccine or history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• 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. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
• History of invasive pneumococcal diseases.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Febrile illness defined as oral, axillary or tympanic temperature greater or equal to 37.5°C, rectal temperature greater or equal to 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Pneumovax™ 23
Hypersensitivity to any component of the vaccine. In the case of fever, acute disease, or relapse of chronic disease, it is preferable to postpone vaccination.
DTPa-HBV-IPV/Hib vaccine
The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens:
DTPa-HBV-IPV/Hib should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B and Hib vaccines or to any component of the vaccines.
DTPa-HBV-IPV/Hib are contra-indicated if the infant has experienced an encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the immunological memory following primary vaccination with either GSK Biologicals’ 10-valent conjugate vaccine or Prevenar™, through the administration of a single booster dose of unconjugated 23-valent pneumococcal polysaccharide vaccine (Pneumovax™23) in children 11-14 months of age.<br><br>;Secondary Objective: To assess the persistence of antibodies induced by either GSK Biologicals’ 10-valent conjugate vaccine or Prevenar™ 7 to 10 months after completion of the 3-dose primary immunization course in study 10PN-PD-DIT-003.<br><br>;Primary end point(s): One month after the administration of the single dose of unconjugated 23-valent pneumococcal polysaccharide vaccine (Pneumovax™ 23): anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater or equal to 0.2 micrograms/mL.