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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Napoli, Campania, 80122 Italy
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
75-105 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Aged 3 months (75 to 105 days) at time of enrollment.

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

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

4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless
of gestational age and birth weight, all subjects must have met inclusion criterion
number 3.

5. Parent(s)/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 Hib.

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® [MedImmune]).

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.

NCT00366899
Pfizer
Completed
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

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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]

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