Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Priorix Tetra TM 208136; Biological: Boostrix Polio™ 711866; Biological: Tetravac TM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871000

111815

Details and patient eligibility

About

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.

In this study, MMRV vaccine will also be co-administered to all children.

Enrollment: 303 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female child of 5 and 6 years of age at the time of vaccination.
• Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the parent or guardian 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 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.

• 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 tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.

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

• Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.

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

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

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

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

• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.

• 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.

• Residence in the same household as a person high risk for varicella

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

  • Current febrile illness or axillary temperature ≥ 38.5 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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303 participants in 2 patient groups

BOOSTRIX POLIO GROUP

Experimental group

Description:

Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.

Treatment:

Biological: Priorix Tetra TM 208136

Biological: Boostrix Polio™ 711866

TETRAVAC GROUP

Active Comparator group

Description:

Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.

Treatment:

Biological: Tetravac TM

Biological: Priorix Tetra TM 208136