Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Tetanus; Acellular Pertussis

Treatments: Biological: Infanrix hexa™; Biological: Prevenar 13®; Biological: GSK217744

Study type: Interventional

Funder types: Industry

Identifiers

NCT01248884

113948

Details and patient eligibility

About

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

Full description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Enrollment: 721 patients

Sex: All

Ages: 60 to 90 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
• Born after a gestation period of 37 to 42 weeks inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

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 vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
• 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.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
• 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 vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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721 participants in 3 patient groups

GSK217744 Group 1

Experimental group

Description:

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Treatment:

Biological: GSK217744

Biological: Prevenar 13®

GSK217744 Group 2

Experimental group

Description:

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Treatment:

Biological: GSK217744

Biological: Prevenar 13®

Infanrix hexa Group

Active Comparator group

Description:

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Treatment:

Biological: Prevenar 13®

Biological: Infanrix hexa™