Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India

Phase 4

Conditions: Health Condition 1: null- Preventive Pneumococcal Infections

Registration Number: CTRI/2014/05/004608

Lead Sponsor: Pfizer Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 1200

Inclusion Criteria

1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject or the subjectâ??s parent/legal guardian has been informed of all pertinentaspects of the study. If a subject or the subjectâ??s parent/legal guardian is illiterate, he/she must make his/her mark (eg, thumbprint) on the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process. If consent is provided by a subjectâ??s parent/legal guardian, the subjectâ??s assent may also be required depending on local requirements.

2.Male or female adults 50 to 65 years of age; or male or female children 6 to 17 years of age at the time of enrollment.

3.Healthy subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of 13vPnC, are eligible.

4.Subjects or the subjectsâ?? parent/legal guardians who are willing and able to comply with scheduled visits and other study procedures.

5.Subjects or subjectsâ?? parent/legal guardians are expected to be available for the duration of the study.

6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is

sexually active.

7.Negative urine pregnancy test for all female subjects who are of childbearing potential.

Exclusion Criteria

1. Subjects or parents/legal guardians who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

2. History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.

3. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or 13vPnC 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.

4. Immunocompromised persons with known or suspected immunodeficiency or who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer, HIV infection, or autoimmune disease.

5. Severe chronic disorder, including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which, in the investigatorâ??s opinion, precludes the subject from participating in the study.

6. Documented Streptococcus pneumoniae infection within the past 5 years before 13vPnC administration.

7. Receipt of any plasma products or immunoglobulins within 60 days preceding 13vPnC administration or anticipated receipt before study completion.

8. Vaccination with any licensed or investigational pneumococcal vaccine within the last

year.

9. Participation in other studies within 28 days before the current study begins and/or during study participation. Participation in observational studies is permitted.

10. Permanent residence in a nursing home, or other residential care facility. An ambulatory subject who is a resident of a retirement home or village is eligible for the study.

11. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception throughout the study.

Inclusion and exclusion criteria for participant selection, including age and sex. Age and sex to be mentioned in specific boxes.