Infections, Rotavirus
Conditions
Keywords
Neonatal vaccination
Brief summary
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.
Interventions
BIOLOGICAL251154 vaccine
Intramuscular, single dose
BIOLOGICALInfanrix hexa™
Intramuscular, four doses
BIOLOGICALSynflorix™
Intramuscular, four doses
BIOLOGICALRotarix™
Oral, two doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 5 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to components of the study vaccines. | One month after the first dose of primary vaccination. |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). | One month after the second dose of primary vaccination. |
| Occurrence of solicited local and general symptoms (on secondary readouts). | On Day 0-Day 7 after neonatal vaccination. |
| Occurrence of unsolicited adverse events (on secondary readouts). | On Day 0-Day 30 after each vaccination. |
| Occurrence of serious adverse events (on secondary readouts). | From enrolment up to study end. |
Outcome results
None listed