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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
Bad Kreuznach, , 55543 Germany
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
56-112 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 (56 to 112 days) at time of enrollment.

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

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

4. Parent(s) or legal guardian(s) had to 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 vaccine.

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

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

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, or 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 or H influenzae type
b.

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,
hydrocephalus, or other significant disorders. Did not include resolving syndromes due
to birth trauma such as Erb palsy.

10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis®).

11. Participation in another investigational trial. Participation in purely observational
studies was acceptable.

12. Infant who was a direct descendant (eg, child or grandchild) of the study site
personnel.

NCT00366340
Pfizer
Completed
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

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[email protected]

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