Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: 251154 vaccine
* Biological: Infanrix hexa™
* Biological: Synflorix™
* Biological: Rotarix™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age. | Biological: 251154 vaccine<br>* Intramuscular, single dose<br>Biological: Infanrix hexa™<br>* Intramuscular, four doses<br>Biological: Synflorix™<br>* Intramuscular, four doses<br>Biological: Rotarix™<br>* Oral, two doses<br>|
| Active Comparator: Group B<br>Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age. | Biological: Infanrix hexa™<br>* Intramuscular, four doses<br>Biological: Synflorix™<br>* Intramuscular, four doses<br>Biological: Rotarix™<br>* Oral, two doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to components of the study vaccines. |  | One month after the first dose of primary vaccination. | 
| Immunogenicity with respect to components of the study vaccines. |  | One month after the third dose of primary vaccination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). |  | One month after the second dose of primary vaccination. | 
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). |  | One month after the third dose of primary vaccination. | 
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). |  | One month after booster vaccination. | 
| Occurrence of solicited local and general symptoms (on secondary readouts). |  | On Day 0-Day 7 after neonatal vaccination. | 
| Occurrence of solicited local and general symptoms (on secondary readouts). |  | On Day 0-Day 3 after each dose of primary and booster 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal vaccination