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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 November 14, 2019

FOR MORE INFORMATION
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.
Show details

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.
Show details

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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Descriptive Information
Brief Title  ICMJE Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionA 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines
Intervention  ICMJE Biological: 13vPnC
All subjects receive a single dose (0.5mL) of 13vPnC
Study Arms  ICMJE Experimental: 13vPnC provided as a 0.5-mL dose in a prefilled syringe
All subjects receive a single dose (0.5mL) of 13vPnC
Intervention: Biological: 13vPnC
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 17, 2019
Actual Primary Completion DateApril 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03777865
Other Study ID Numbers  ICMJE B1851190
13VPNC 6 TO 17 YEARS IN INDIA ( Other Identifier: Alias Study Number )
2019-000890-21 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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