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

GlaxoSmithKline Biologicals0 sites120 target enrollmentMay 4, 2006

ConditionsA 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.

DrugsPneumovax 23 Infanrix Hexa

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 120
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 4, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

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

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.