You are here

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

Last updated on December 18, 2018

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India
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
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Vaccines
Biological: 13vPnC
All subjects receive a single dose (0.5mL) of 13vPnC
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Same as current
April 30, 2019
April 30, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
India
 
 
NCT03777865
B1851190
13VPNC 6 TO 17 YEARS IN INDIA ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2018

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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now