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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on March 14, 2019

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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 Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 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 through 98 days) at the time of enrollment.

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

3. In good health as determined by medical history, physical examination, and judgment of
the investigator.

4. Parent(s)/legal guardian(s) were 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 vaccine.

2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio
vaccines.

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

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, or pneumococcal vaccines.

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

6. Known or suspected immune deficiency or suppression.

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

8. Major known congenital malformation or serious chronic disorder.

9. Significant neurological disorder or history of seizure (including febrile seizure),
or significant stable or evolving disorders (such as cerebral palsy, encephalopathy,
or hydrocephalus), or other significant disorders. This did not include resolving
syndromes because of birth trauma such as Erb palsy.

10. Receipt of blood products or ?-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies [eg, Synagis]).

NCT00366548
Pfizer
Completed
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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[email protected]

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