Status:
COMPLETED
Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Tetanus
Eligibility:
All Genders
5-6 years
Phase:
PHASE3
Brief Summary
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2009
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00871000
Start Date
April 1 2009
End Date
November 18 2009
Last Update
June 6 2018
Active Locations (8)
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1
GSK Investigational Site
Genoa, Liguria, Italy, 16132
2
GSK Investigational Site
Milan, Lombardy, Italy, 20122
3
GSK Investigational Site
Novara, Piedmont, Italy, 28100
4
GSK Investigational Site
Cagliari, Sardinia, Italy, 09127