A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given in healthy infants at 3, 5 and 11 months of age. - DTPA-HBV-IPV=HIB-MENC-TT-001 PRI

GlaxoSmithKline Biologicals0 sites16 target enrollmentJanuary 26, 2009

DrugsInfanrix Hexa

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 16
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 26, 2009

End Date

June 25, 2009

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
•Born after a gestation period of 36 to 42 weeks inclusive.
•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).
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•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 \>\=0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4\.
•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.
•Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
•History of seizures or progressive neurological disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness.