Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Condition: Vaccines
Intervention: 13vPnC
Intervention description: 13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Minimum age: 42 Days
Maximum age: 72 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent
      Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine
      Pediatric Vaccines In Healthy Infants In India
    

Eligibility criteria:

        Inclusion Criteria:

          1. Evidence of a personally signed and dated informed consent document indicating that
             the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the
             study.

          2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled
             visits, treatment plan, and other study procedures.

          3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is
             considered Day 0.)

          4. Available for the entire study period and whose parent(s)/legal
             guardian(s)/caregiver(s) can be reached by telephone.

          5. Healthy infant as determined by medical history, physical examination, and judgment of
             the investigator.

          6. Weight of 3.0 kg or greater at the time of vaccination.

        Exclusion Criteria:

          1. Infant who is a direct descendant (child, grandchild) of

               -  Investigator site staff members directly involved in the conduct of the study, or

               -  Site staff members otherwise supervised by the investigator, or

               -  Pfizer employees directly involved in the conduct of the study.

          2. Participation in other studies involving investigational drug(s) within 28 days prior
             to study entry and/or during study participation. Participation in purely
             observational studies is acceptable.

          3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.

          4. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other
             vaccine or vaccine component. Bleeding diathesis or condition associated with
             prolonged bleeding time that would contraindicate intramuscular injection.

          6. Known or suspected immune deficiency or suppression, including known human
             immunodeficiency virus infection.

          7. Major known congenital malformation or serious chronic disorder.

          8. Significant neurological disorder or history of seizure including febrile seizure, or
             significant stable or evolving disorders such as cerebral palsy, encephalopathy,
             hydrocephalus, or other significant disorders. Does not include resolving syndromes
             due to birth trauma such as Erb's palsy.

          9. Other acute or chronic medical condition including recent laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study.

         10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and
             monoclonal antibodies, eg, Synagis).