Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: RepevaxTM; Biological: PriorixTM; Biological: Boostrix PolioTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245049

111763

Details and patient eligibility

About

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Enrollment: 387 patients

Sex: All

Ages: 3 to 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
• Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
• 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 vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.

• 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.

• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.

• Previous measles, mumps and/or rubella second dose vaccination.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.

• Known exposure to measles, mumps and/or rubella within 30 days prior to study start.

• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

• Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.

• Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:

  • Hypersensitivity reaction to any component of the vaccine;
  • Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
  • Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
  • Collapse or shock-like state within 48 hours of vaccination;
  • Convulsions with or without fever, occurring within 3 days of vaccination.

• Acute disease and/or fever at the time of enrolment or 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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387 participants in 2 patient groups

BOOSTRIX POLIO GROUP

Experimental group

Description:

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

Treatment:

Biological: Boostrix PolioTM

Biological: PriorixTM

REPEVAX GROUP

Active Comparator group

Description:

Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

Treatment:

Biological: RepevaxTM

Biological: PriorixTM