A phase II, open-label, randomised study to assess the safety and immunogenicity of a birth dose of GSK Biologicals’ reduced-antigen-content tri-component pertussis vaccine followed by routine paediatric vaccination at 2, 4, 6 and 12-18 months of age, and to explore the ability of this schedule to accelerate the acquisition of pertussis antibodies. - PA-TRICOMP-005

Phase 1

Conditions: Primary and booster immunisation of healthy infants in the first two years of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, rotavirus and pneumococcal diseases.
MedDRA version: 12.1Level: LLTClassification code 10043376Term: Tetanus
MedDRA version: 12.1Level: LLTClassification code 10013023Term: Diphtheria
MedDRA version: 12.1Level: LLTClassification code 10034738Term: Pertussis
MedDRA version: 12.1Level: LLTClassification code 10019731Term: Hepatitis B
MedDRA version: 12.1Level: LLTClassification code 10036012Term: Poliomyelitis
MedDRA version: 12.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infection
MedDRA version: 12.1Level: LLTClassification code 10067470Term: Rotavirus infection
MedDRA version: 12.1Level: LLTClassification code 10061353Term: Pneumococcal infection

Registration Number: EUCTR2009-012460-14-BE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 376

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:
-Subjects who the investigator believes that their parent(s)/LAR(s) 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(s)/LAR(s) of the subject.
-A male or female infant between, and including, 0 and 7 days of age at the time of
randomisation.
-Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks
inclusive.
-Subjects born to a mother seronegative for hepatitis B surface antigen.
-Subjects with a birth weight >= 2.5 kg.
-Subjects with a 5-minute Apgar score >= 7.
-Healthy subjects as established by medical history and clinical examination.
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 vaccines since birth, or planned use during the study period.
-Born to a mother known or suspected to be seropositive for HIV (testing not required for inclusion).
-Family history of congenital or hereditary immunodeficiency.
-Children in care.
-Neonatal jaundice requiring systemic treatment (light therapy is allowed).
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
-Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines, which can be administered seven days away from any dose of the study vaccine. The administration of routinely recommended vaccines (e.g. meningococcal serogroup C conjugate vaccine, measles-mumps-rubella vaccine) is allowed during the period from completion of all study-related procedures at study Visit 7 to 30 days before study Visit 8.
-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).
-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 vaccines.
-Major congenital defects or serious chronic illness, including perinatal brain damage.
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 or temperature >= 37.5°C on axillary setting, or >= 38.0°C on
rectal setting, 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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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