Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

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.

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Detailed Description

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Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

251154 vaccine

Intramuscular, single dose

Intervention Type BIOLOGICAL

Infanrix hexa™

Intramuscular, four doses

Intervention Type BIOLOGICAL

Synflorix™

Intramuscular, four doses

Intervention Type BIOLOGICAL

Rotarix™

Oral, two doses

Intervention Type BIOLOGICAL

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.

• 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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes