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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-04-17

Brief Summary

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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.

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Detailed Description

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A Phase 4, open-label, single-arm, multicenter study to describe the safety of 13-valent Pneumococcal Conjugate Vaccine in children 6 to 17 years of age in India.

Conditions

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Vaccines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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13vPnC provided as a 0.5-mL dose in a prefilled syringe

All subjects receive a single dose (0.5mL) of 13vPnC

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

All subjects receive a single dose (0.5mL) of 13vPnC

Interventions

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13vPnC

All subjects receive a single dose (0.5mL) of 13vPnC

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes