Maternal Immunization To Prevent Infant Otitis Media

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Otitis Media

In brief

The main objective of this study is to evaluate whether immunization with 9-valent pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six months of life.

Key facts

Study ID

NCT00617682

Run by

National Institute on Deafness and Other Communication Disorders (NIDCD)

People needed

153

Starts

2000-10-01

Expected to finish

2004-12-01

Last updated by the study team

2008-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HealthPartners Research Foundation — Bloomington, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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