A phase IIIb, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals? dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi-Pasteur-MSD?s DTPa-IPV (Tetravac), when co-administered with MMRV (Priorix Tetra) in 5 to 6-year-old healthy children. - dTpa-IPV-010

Conditions: Booster immunisation of healthy preschool children against diphtheria, tetanus, pertussis, poliomyelitis, mumps, measles and rubella
and first or second immunisation of healthy preschool children against varicella.
MedDRA version: 9.1Level: LLTClassification code 10034738
MedDRA version: 9.1Level: LLTClassification code 10013023
MedDRA version: 9.1Level: LLTClassification code 10043376
MedDRA version: 9.1Level: LLTClassification code 10036012

Registration Number: EUCTR2008-006124-64-IT

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

A male or female child of 5 and 6 years of age (up to, but excluding 7 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. The first two vaccine doses must have been administered before 9 months of age, the third dose must have been received between 10 and 18 months of age, and there must have been at least one month between each vaccination. - 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 (e.g. completion of the diary cards, return for follow-up visits) 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent Inhaled and topical steroids are allowed. - 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 (pharmaceutical product or device). - 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 (no laboratory testing required). - 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 (AEs) 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 ≥ 40C (axillary temperature/oral temperature) within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination. - Residence in the same household as a high risk person for varicella e.g.: Newborn infant (0-4 weeks of age) Pregnant women who have a negative history for chickenpox Persons with known immunodeficiency - 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