A phase III, open, controlled, multi-centric study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine when administered to children aged between 2 to17 years who are at an increased risk of pneumococcal infection and to an age-matched control group of healthy children aged 24 to 59 months. - 10PN-PD-DIT-072

GlaxoSmithKline Biologicals0 sites100 target enrollmentApril 2, 2013

ConditionsActive immunization against disease caused by Streptococcus pneumoniae in children 2-17 years of age who are at increased risk of pneumococcal infection.MedDRA version: 16.1Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862 MedDRA version: 16.1Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862 MedDRA version: 16.1Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862 MedDRA version: 16.1Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862 Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsSynflorix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Active immunization against disease caused by Streptococcus pneumoniae in children 2-17 years of age who are at increased risk of pneumococcal infection.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 100
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 2, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility 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).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
•Female subjects of non\-childbearing potential may be enrolled in the study. (Non\-childbearing potential is defined as pre\-menarche, current tubal ligation, hysterectomy or ovariectomy).
•Please refer to the GLOSSARY OF TERMS for the definition of menarche.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
•\-has practiced adequate contraception for 30 days prior to vaccination, and
•\-has a negative pregnancy test on the day of vaccination, and
•\-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
•Priming status:
•\- Children who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn\-PD\-DiT), Prevenar or Prevenar13 will be considered for inclusion in the unprimed groups.

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.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine(s) and ending 30 days after\*
•\* In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, vaccines can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. Vaccines that are recommended for subjects with an increased risk of bacterial infection (for example meningococcal, Hib vaccines, etc, except a pneumococcal vaccine), can be administered at any time to the subjects enrolled in the At\-risk group.
•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).
•History of any neurological disorders or seizures.
•Acute disease and/or fever at the time of enrolment.
•\-Fever is defined as temperature \= 37\.5°C on oral, axillary or tympanic setting, or \= 38\.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary.
•\-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•History of chronic alcohol consumption and/or drug abuse.