Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A.; Infanrix hexa.; Meningococcal vaccine GSK134612.; Paracetamol.
Intervention description: 1 intramuscular injection.; 1 intramuscular injection.; 1 intramuscular injection.; Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.
Intervention MeSH terms: Acetaminophen; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus Pneumoniae Vaccines; Meningococcal disease; Carriage; Prophylactic antipyretic; Safety; Pneumococcal vaccine; Fever; Pneumococcal disease; Immunogenicity; Meningococcal vaccine; Booster vaccination

Summary:

      The purpose of this trial is to assess if the rate of febrile reactions following the
      co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant
      vaccines is lowered when paracetamol is given prophylactically and to assess the impact of
      pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage
      compared to control group receiving meningococcal conjugate vaccine (GSK134612).

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00370318).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  A male or female between, and including, 12-15 months of age at the time of the
             vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Subjects in the unprimed group

        • A male or female who previously participated in study 107017 and received 3 doses of
        pneumococcal conjugate vaccine GSK1024850A.

        Exclusion Criteria:

        For all subjects:

          -  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 antipyretic
             treatment.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within one month preceding the dose of study vaccines, or planned use
             during the entire study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to the dose of study vaccines.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol,
             during the period starting one month before the dose of study vaccines and up to one
             month after the dose of study vaccines.

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b disease.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of seizures (this criterion does not apply to subjects who have had a single,
             uncomplicated febrile convulsion in the past) or progressive neurological disease.

          -  Acute disease at the time of enrolment.

          -  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 within three months
             preceding administration of the dose of study vaccines or planned administration
             during the study period.

          -  Subjects of which both parents have a history of atopia.

          -  Subject has received systemic antibiotic therapy for acute illness within 24 hours
             prior to the vaccination.

          -  Subject is likely to receive antipyretic treatment as a result of a concomitant
             illness or has been treated with paracetamol within the past 24 hours.

        DTPa-HBV-IPV/Hib vaccine:

          -  Known hypersensitivity after previous administration of diphtheria, tetanus,
             pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.

          -  Encephalopathy.

          -  As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in
             subjects suffering from acute mild, moderate or severe illness.

        For subjects in the AP-AP, AP-NAP and NAP groups:

        • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B
        and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.

        For subjects in the AP-AP group:

        • Subject with any contraindication to treatment with paracetamol.

        For subjects in the unprimed group:

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C,
             W-135 and/or Y.

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups
             A, C, W-135 and/or Y.

          -  Planned administration of a hepatitis B vaccine not foreseen by the study protocol
             during the period starting one month after the dose of study vaccines and up to study
             end.

          -  Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT,
             DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.

          -  History of meningococcal disease due to serogroup A, C, W, or Y.

          -  Administration of any pneumococcal vaccine since birth.

          -  Full vaccination history since birth not available.