A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age - DTPA-IPV=HIB-MENC-TT-001 PRI

GlaxoSmithKline Biologicals0 sites280 target enrollmentApril 27, 2009

DrugsMenitorix Menjugate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 280
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

April 27, 2009

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:
•A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
•Born after 36 to 42 weeks of gestation.
•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.
•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

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 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.
•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 vaccination, or planned administration during the study period.
•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).
•Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
•History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).