Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: GSK1024850A (SynflorixTM); Infanrix hexa; Infanrix-IPV/Hib; Ibuprofen; Paracetamol
Intervention description: Intramuscular injection, 4 doses; Intramuscular injection, 3 doses; Intramuscular injection, 1 dose; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 850.0
Sex: All
Minimum age: 12 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine; Immunogenicity; Safety; Fever; Primary vaccination; Booster vaccination; Pneumococcal disease; Prophylactic antipyretic

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 children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals'
      10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3,
      4 and 5 months of age.

      In addition, this study will further evaluate the impact of prophylactic administration of
      paracetamol following primary vaccination with immediate or delayed administration or when
      given in an immediate manner at the time of the booster dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.