Maternal Immunization To Prevent Infant Otitis Media

This is an interventional prevention trial for Otitis Media focused on measuring Maternal immunization, Pneumococcal conjugate vaccine, Otitis media Read More

Inclusion Criteria:

Maternal inclusion criteria:

• Pregnant, at least 18 yrs of age and healthy based on medical history.
• Plans to continue HealthPartners insurance coverage until infant is 13 mos old; mother and child will receive care in staff model clinic participating in the study, and obstetric care will be provided by a HP obstetrician/CNM with delivery at affiliated hospital.
• Plans to reside in Twin Cities metro area until infant is 13 mos old.
• Has a residence phone and a back-up phone contact.
• Provides informed consent.

Infant inclusion criteria:

• Infants born to enrolled women.

Exclusion Criteria:

Maternal exclusion criteria:

• Known hypersensitivity to any of the vaccine components or to latex.
• Prior vaccination with any S. pneumoniae vaccine.
• Recent (w/in 2 mos) vaccination with diphtheria or tetanus-diphtheria toxoid vaccines. Administration of influenza, or any other vaccine, or RhoGAM in the 2 wks prior to administration of the study product.
• Known history of life-threatening pneumococcal infection.
• Known impairment of immunologic function or history of immunodeficiency.
• Previous child with a major congenital anomaly or fetal malformation.
• Known to be carrying more than one fetus.
• Any medical condition or history that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
• History of preterm birth or fetal death.
• Known history of chronic hypertension, severe pre-eclampsia in a previous pregnancy, current pre-eclampsia or any type of diabetes mellitus.
• Known anatomical defects of the cervix or uterus.
• Known history of teratogenic drug use or illegal substance abuse during current pregnancy, not including tobacco or alcohol use.
• Women who have tested positive (based on medical record information) for HIV or hepatitis B infection.
• Any contraindication specified in the vaccine manufacturer's CIB.
• History of febrile illness (temp 100.0 degrees F or over) during the 72 hrs prior to vaccine administration.
• History of significant mental illness (e.g. schizophrenia, psychoses, major depression).

Infant exclusion criteria:

• Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
• Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
• Latex sensitivity.
• Known impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection, or other causes that may reduce antibody response to active immunization.
• Vaccination may be delayed because of a current or recent febrile illness depending largely on the severity of the symptoms and their etiology. Although a severe or even a moderate febrile illness is sufficient reason to postpone vaccinations, minor illnesses, such as a mild upper respiratory infection with or without low-grade fever, are not generally contraindications.