Status:
COMPLETED
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
12-16 years
Phase:
PHASE4
Brief Summary
The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in ...
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.
- A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion
- Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use 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 (.
- Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
- Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
- History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
- History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
- History of any seizures or progressive neurological disease.
- Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
- Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
- Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
- Body weight \< 5 kg at the time of enrolment.
- Child in care.
Key Trial Info
Start Date :
November 12 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2012
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT01235949
Start Date
November 12 2010
End Date
December 8 2012
Last Update
May 10 2019
Active Locations (23)
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1
GSK Investigational Site
Bacau, Romania, 600316
2
GSK Investigational Site
Brasov, Romania, 500063
3
GSK Investigational Site
Brasov, Romania, 500260
4
GSK Investigational Site
Brasov, Romania, 500366