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Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
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
90-120 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Chinese infants, aged 3-4 months (90-120 days) at enrollment, and have not received
their 1st dose of DTaP

- In good health determined by medical history, physical examination (axillary
temperature and weight) and clinical judgment of the investigator

- An informed consent form must be signed by at least one of the parent/legal guardian.
The parent or legal guardian are willing to adhere to the regimen of the study and are
capable of using the thermometer, calipers and filling out the diary card

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Weight

- History of neurological disorders including a personal and family history of
convulsion and epilepsy (including febrile seizures)

- Receipt of blood products, including gamma globulin within 12 weeks prior to study
entry

- Hypersensitivity to any component of 7vPnC, including diphtheria toxoid

- Known previous anaphylactic reactions to any vaccines or medicines

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

- Known or suspected impairment of immune function due to the use of immunosuppressive
therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents,
and cytotoxic agents), a genetic defect, HIV infection or other cause

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

- Any significant congenital deformity or serious chronic diseases

- Previous immunization with licensed or investigational pneumococcal vaccine

- Other investigational medicine is being administered or has been administered within
12 weeks before screening or participation in another investigational study

NCT00488826
Pfizer
Completed
Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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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