Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
Sex
Ages
Volunteers
Inclusion criteria
- Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- A male or female infant between, and including, 2 and 5 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
Exclusion criteria
- Use of any investigational or non-registered product 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.
- Family history of congenital or hereditary immunodeficiency.
- Children in care..
- Neonatal jaundice requiring systemic treatment.
- 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.
- 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.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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 >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal