Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Poliomyelitis Vaccines

Treatments: Biological: Poliorix™; Biological: Oral Poliovirus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021293

112679

2011-003167-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

Enrollment: 1,101 patients

Sex: All

Ages: 60 to 90 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine(s) 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 immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
• 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 poliomyelitis disease or vaccination.
• 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 vaccine(s).
• Major congenital defects or serious chronic illness.
• Child in care.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,101 participants in 2 patient groups

Poliorix Group

Experimental group

Description:

Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.

Treatment:

Biological: Poliorix™

Control Group

Active Comparator group

Description:

Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

Treatment:

Biological: Oral Poliovirus vaccine