Clinical trial NCT01110044: Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
Official title: Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Infections, Rotavirus
Keywords: Neonatal vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immunogenicity with respect to components of the study vaccines.
timeFrame: One month after the first dose of primary vaccination.
measure: Immunogenicity with respect to components of the study vaccines.
timeFrame: One month after the third dose of primary vaccination.
Secondary outcomes:
measure: Immunogenicity with respect to components of the study vaccines (on secondary readouts).
timeFrame: One month after the second dose of primary vaccination.
measure: Immunogenicity with respect to components of the study vaccines (on secondary readouts).
timeFrame: One month after the third dose of primary vaccination.
measure: Immunogenicity with respect to components of the study vaccines (on secondary readouts).
timeFrame: One month after booster vaccination.
measure: Occurrence of solicited local and general symptoms (on secondary readouts).
timeFrame: On Day 0-Day 7 after neonatal vaccination.
measure: Occurrence of solicited local and general symptoms (on secondary readouts).
timeFrame: On Day 0-Day 3 after each dose of primary and booster vaccination.
measure: Occurrence of unsolicited adverse events (on secondary readouts).
timeFrame: On Day 0-Day 30 after each vaccination.
measure: Occurrence of serious adverse events (on secondary readouts).
timeFrame: From enrolment up to study end.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: