A phase III, randomized, open, controlled study in healthy Japanese children to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa vaccine as a 3-dose pri-mary immunization course at 3, 4 and 5 months of age and followed by a booster vaccination at 17-19 months of age. - 10PN-PD-DIT-058

GlaxoSmithKline Biologicals0 sites360 target enrollmentMay 13, 2015

DrugsSynflorix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 360
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

May 13, 2015

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/co\-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
•A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
•Written informed consent obtained from the par\-ent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born after a gestation period of 36 to 42 weeks inclusive.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 360
•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

Exclusion Criteria

•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
•Chronic administration of immunosuppressants or other immune\-modifying drugs since birth.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette\-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
•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).
•Administration of any pneumococcal vaccine since birth except for subjects receiving the DTPa vaccine only (DTPa Group) for whom vaccination with a licensed pneumococcal vaccine by catch\-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4\) onwards and up to 7 days before the booster dose of the DTPa vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of, or intercurrent diphtheria, tetanus, pertussis disease.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
•Major congenital defects or serious chronic illness.
•History of any seizures or progressive neurological disease.