Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age.
Condition or disease
Biological: 7-valent pneumococcal conjugate vaccineBiological: Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)
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Ages Eligible for Study:
90 Days to 120 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Weight < 2 SD for age
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