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 to healthy infants at 2, 4 and 12 months of age. - DTPA-HBV-IPV=HIB-MENC-TT-003

• Conditions: Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningococcal, rotavirus and pneumococcal diseases.; MedDRA version: 14.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10043376Term: TetanusSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10067470Term: Rotavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10013023Term: DiphtheriaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10036012Term: PoliomyelitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2009-016635-36-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) 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 infant between, and including, 8 and 12 weeks at the time of the first vaccination.
-Born after a gestation period of 36 to 42 weeks inclusive.
-Written informed consent obtained from the parent(s) LAR(s) 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 exclusion
criterion applies, 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 = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Child in care.
• 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 the end of the
study with the exception of inactivated influenza vaccines. The administration of
diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal,
rotavirus and/or MenC vaccines is not allowed at any time during the study period
but other vaccines are 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 (pharmaceutical product or device).
• Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib,
pneumococcal, rotavirus 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 (no laboratory testing required).
History of any reaction or hypersensitivity 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 if no other exclusion criteria is met:
• Current febrile illness (axillary temperature = 38.5 ºC or rectal temperature = 39.0°C)
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