Immunogenicity and safety study of GSK Biologicals’ Infanrix hexa™ when administered in healthy infants at 2, 4 and 6 months of age.

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 585

Inclusion Criteria

Subjects’ parents/ Legally Acceptable Representatives who, in the opinion of the investigator, can and will comply, with the requirements of the protocol
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Born full-term.
Written informed consent obtained from parents/LARs of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 585
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Child in care
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 and from 30 days before the booster Dose 4 until 30 days after booster Dose 4.
Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
Routine administrations of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days be-fore booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
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 Hib, diphtheria, tetanus, pertussis, pneumo-coccal, rotavirus, poliovirus and hepatitis B diseases.
Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
Major congenital defects or serious chronic illness.
History of any neurological disorders including seizures.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
History of Severe Combined Immunodeficiency Disease.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature = 38.0°C /100.4°F by any route. The preferred route for recording tempera-ture in this study will be rectal for Epoch 001 and axillary for Epoch 002.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 5/21/2024

Immunogenicity and safety study of GSK Biologicals’ Infanrix hexa™ when administered in healthy infants at 2, 4 and 6 months of age.

Recruitment & Eligibility

Study & Design

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