Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
Condition: Hepatitis B; Acellular Pertussis; Tetanus; Poliomyelitis; Diphtheria; Streptococcus Pneumoniae Vaccines
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Pneumonia, Pneumococcal
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Prevenar; Infanrix hexa; Infanrix IPV Hib; Infanrix penta; Infanrix IPV; Meningitec; NeisVac-C; Menitorix
Intervention description: Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose. In Germany and Poland.; Intramuscular injection, 1 dose. In Spain.; Intramuscular injection, 1 dose. In Germany and Poland.; Intramuscular injection, 1 dose. In Spain.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1437.0
Sex: All
Minimum age: 11 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fever.; Meningococcal disease.; Pneumococcal disease.; Meningococcal vaccine.; Pneumococcal vaccine.; Immunogenicity.; Booster vaccination.; Safety.

Summary:

      The purpose of this study is to assess the safety in terms of fever (rectal temperature)
      higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response
      following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of
      age in children previously primed with the same vaccines including a pneumococcal conjugate
      vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and
      meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus
      influenzae type b (Hib-MenC) vaccine.

      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 = NCT00334334).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 11-18 months of age at the time of the
             booster vaccination.

          -  A male or female who previously participated in study 107005 and received three doses
             of pneumococcal conjugate vaccine.

          -  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.

        Exclusion Criteria:

          -  Concurrently participating in another clinical study, at any time during the study
             period (active phase and extended safety follow-up), in which the subject has been or
             will be exposed to an investigational or a non-investigational product.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within one month preceding the booster 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 booster dose of study vaccines.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol,
             during the period starting one month before the booster dose of study vaccines and up
             to the follow-up visit (one month after the booster dose of study vaccines).

          -  Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis
             B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study
             vaccines from study 107005.

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, meningococcal serogroup C 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 the booster dose of study vaccines or planned administration during the
             active phase of the study (starting with the administration of the booster dose of
             study vaccines up to the follow-up visit one month after).