A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT) co-administered with Infanrix hexacompared to individual administration of each vaccine, in healthy 12- through 23-month-old children - MenACWY-TT-040

GlaxoSmithKline Biologicals0 sitesJune 4, 2007

ConditionsOne dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 months

DrugsMeningitec Infanrix hexa

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 months
Sponsor: GlaxoSmithKline Biologicals
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

June 4, 2007

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

•All subjects must satisfy the following criteria at study entry:
•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, 12 and 23 months 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.
•Documented three\-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination. This will be recorded in the subject’s eCRF.
•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

Exclusion Criteria

•The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•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, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean \>\= 0\.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
•Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
•Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
•Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.
•History of meningococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
•History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).