A phase III randomised, controlled study to assess in a double blind manner the lot-to-lot consistency of three consecutive production lots of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine and to evaluate the non-inferiority to Prevenar™ in a single blind design, when administered as a 3-dose primary immunization course before 6 months of age. - 10PN-PD-DIT-001

GlaxoSmithKline Biologicals0 sites1,600 target enrollmentAugust 30, 2005

DrugsInfanrix hexa Prevenar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 1600
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

August 30, 2005

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 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 between, and including, 6 and 12 weeks (42\-90 days) of age at the time of the first vaccination.
•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.
•Born after a gestation period of 36 to 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 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 one month before the first dose of vaccine(s) and during the entire study period.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of Poland where the first dose of hepatitis B will be given at birth.
•History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•History of any neurologic disorders or seizures.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low\-grade febrile illness, i.e oral/axillary/tympanic temperature \<37\.5°C / rectal temperature \<38\.0°C. Study entry should be delayed until the illness has improved.
•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, higher than or equal to 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.).
•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.