Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 7-valent pneumococcal conjugate vaccine; Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 800.0
Sex: All
Minimum age: 90 Days
Maximum age: 120 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines, Pneumococcal Conjugate Vaccine

Summary:

      This study is a combination of a Phase I and Phase III study design. The Phase I portion is
      an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants.
      The Phase III portion is an open-label, controlled, randomized study to evaluate the safety
      and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese
      infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and
      /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5
      months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of
      age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese infants, aged 3-4 months (90-120 days) at enrollment, and have not received
             their 1st dose of DTaP

          -  In good health determined by medical history, physical examination (axillary
             temperature and weight) and clinical judgment of the investigator

          -  An informed consent form must be signed by at least one of the parent/legal guardian.
             The parent or legal guardian are willing to adhere to the regimen of the study and are
             capable of using the thermometer, calipers and filling out the diary card

        Exclusion Criteria:'

          -  Weight < 2 SD for age

          -  History of neurological disorders including a personal and family history of
             convulsion and epilepsy (including febrile seizures)

          -  Receipt of blood products, including gamma globulin within 12 weeks prior to study
             entry

          -  Hypersensitivity to any component of 7vPnC, including diphtheria toxoid

          -  Known previous anaphylactic reactions to any vaccines or medicines

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection

          -  Known or suspected impairment of immune function due to the use of immunosuppressive
             therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents,
             and cytotoxic agents), a genetic defect, HIV infection or other cause

          -  History of culture-proven invasive disease caused by S. pneumoniae

          -  Any significant congenital deformity or serious chronic diseases

          -  Previous immunization with licensed or investigational pneumococcal vaccine

          -  Other investigational medicine is being administered or has been administered within
             12 weeks before screening or participation in another investigational study