Status:
COMPLETED
Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Poliomyelitis
Eligibility:
All Genders
3-4 years
Phase:
PHASE3
Brief Summary
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 Priorix...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2012
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT01245049
Start Date
April 1 2011
End Date
April 2 2012
Last Update
August 17 2018
Active Locations (13)
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1
GSK Investigational Site
St Austell, Cornwall, United Kingdom, PL26 7RL
2
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
3
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
4
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 1XQ