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Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India

Last updated on March 14, 2019

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Study Location
KEM Hospital Research Centre
Pune, Maharashtra, 411 011 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT03777865
Pfizer
Not yet recruiting
Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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