Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India
Condition: Vaccines
Intervention: 13vPnC
Intervention description: All subjects receive a single dose (0.5mL) of 13vPnC
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 4, open-label, single-arm, multicenter study in which subjects 6 to 17 years
      of age will receive 1 dose of 13vPnC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject's parent(s)/legal guardian(s) has/have been informed of all pertinent
             aspects of the study.

             Note: The subject's assent may also be required depending on local requirements.

          2. Healthy male or female children 6 to 17 years of age at the time of vaccination.

          3. Parent(s)/legal guardian(s)/child willing and able to comply with scheduled visits,
             treatment plan, and other study procedures.

          4. Male subject not able to father children, male subject who is able to father children
             and willing to use a highly effective method of contraception, female subject not of
             childbearing potential, or female subject of childbearing potential and at risk for
             pregnancy who is willing to use a highly effective method of contraception.

        Note: Female subjects of childbearing potential are defined as female subjects 9 years old
        or have experienced menarche, whichever is earlier, and who are anatomically and
        functionally able to conceive.

        Exclusion Criteria:

          1. Child who is a family member of:

               -  Investigator site staff members directly involved in the conduct of the study;

               -  Site staff members otherwise supervised by the investigator;

               -  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 observational
             studies is permitted.

          3. History of severe adverse reaction, including hypersensitivity such as anaphylaxis,
             associated with a vaccine or vaccine component.

          4. Contraindication to vaccination with pneumococcal conjugate vaccines (refer to local
             package insert).

          5. Previous vaccination with licensed or investigational pneumococcal vaccine.

          6. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          7. History of culture-proven invasive disease caused by S pneumoniae.

          8. Major known congenital malformation or serious chronic disorder.

          9. Known or suspected immune deficiency or suppression.

         10. Other acute or chronic medical or psychiatric condition including recent (within the
             past year) or active suicidal ideation or behavior or 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.

         11. Pregnant females; breastfeeding females; fertile males and females of childbearing
             potential who are unwilling or unable to use a highly effective method of
             contraception as outlined in this protocol for the duration of the study.