A phase III, randomized, open, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course at 6, 10 and 14 weeks of age in Sub-Saharan Africa, co-administered with GSK Biologicals’ DTPw-HBV/Hib and OPV vaccines. - 10PN-PD-DIT-032 PRI

GlaxoSmithKline Biologicals0 sites365 target enrollmentMay 13, 2015

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy volunteers (Three dose primary vaccination of healthy infants against Streptococcus pneumonia, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and polio diseases)
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 365
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

May 13, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female subjects between, and including 6\-10 weeks of age at the time of the first vaccination.
•Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the require\-ments of the protocol should be enrolled in the study.
•Written or oral, signed or thumb\-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
•Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 365
•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

•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
•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).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs since birth.
•A family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
•Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
•History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•History of any neurological disorders or seizures.