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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Bydgoszcz, , 85-168 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7 + months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Aged from 7 months to

2. Available for entire study period and whose parent/legal guardian could be reached by
telephone.

3. Healthy as determined by medical history, physical examination, and judgment of the
investigator.

4. Parent/legal guardian had to be able to complete all relevant study procedures during
subject participation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Contraindication to vaccination with pneumococcal vaccine.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

5. Known or suspected immune deficiency or suppression.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorders.

8. Significant neurological disorder or history of seizure including febrile seizure, or
significant stable or evolving disorders such as cerebral palsy, encephalopathy,
hydrocephalus, or other significant disorders. Does not include resolving syndromes
due to birth trauma such as Erb palsy.

9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the
last 3 months.

10. Participation in another investigational or interventional trial. Participation in
purely observational studies is acceptable.

11. Child is a direct descendant (child or grandchild) of a member of the study site
personnel.

NCT00452452
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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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]

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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