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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Torun, Bydgoszcz, 87-100 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
41-99 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Aged 2 months (42 to 98 days) at time of enrollment.

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

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

4. Parent/legal guardian must be able to complete all relevant study procedures during
study 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, Hib conjugate,
diphtheria, tetanus, pertussis, or polio vaccines.

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

3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.

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 hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis®).

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

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

NCT00464945
Pfizer
Completed
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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[email protected]

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