An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010

GlaxoSmithKline Biologicals0 sites150 target enrollmentSeptember 27, 2004

DrugsInfanrix hexa Infanrix penta Prevenar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 150
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 27, 2004

End Date

TBD

Last Updated

14 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 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) should be enrolled in the study.
•A male or female between, and including, 8 and 12 weeks (56\-90 days) of age at the time of enrollment.
•Written informed consent obtained from the parents or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Born after a gestation period between 36 and 42 weeks.
•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

Exclusion Criteria

•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 since birth. (For corticosteroids, this will mean prednisone, or equivalent, ? 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease and/or S. pneumoniae.
•History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, meningococcal serogroup C disease and/or invasive pneumococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
•Major congenital defects or serious chronic illness.