Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Synflorix; Tritanrix-HepB; Hiberix; Polio Sabin; Poliorix; Prevenar (Wyeth)
Intervention description: Intramuscular injection, 1 dose; Intramuscular injection, 1 dose; Reconstituted with Tritanrix-Hep B before injection; Oral, 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: Double (Care Provider, Outcomes Assessor)
Enrollment: 756.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Booster vaccination.; Immunogenicity; Pneumococcal vaccine; Safety; Pneumococcal disease

Summary:

      The purpose of this observer blind study is to assess the safety in terms of fever >39°C
      (rectal temperature) and the immunogenicity in terms of antibody response following a booster
      vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children
      previously primed with the same vaccines including a pneumococcal conjugate vaccine
      co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and
      OPV or IPV vaccines. Subjects participating in this study should have received three doses of
      pneumococcal conjugate vaccine in the primary study.

      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 = NCT00344318)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 12-18 months of age at the time of the
             booster vaccination and who previously participated in study 107007 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 (pharmaceutical
             product or device).

          -  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.

          -  Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis
             B, Haemophilus influenzae type b vaccine other than the study vaccines from study
             107007.

          -  History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b diseases.

          -  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.