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

• Conditions: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b (Hib), serogroup C meningococcal and Streptococcus pneumoniae diseases.Booster immunisation of healthy one-year-old children against Hib and serogroup C meningococcal diseases

• Registration Number: EUCTR2008-003741-87-GB
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 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).
• Major congenital defects or serious chronic illness.
The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature >=37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified