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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00617682 |
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.
Condition | Intervention | Phase |
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Otitis Media |
Biological: PNCRM9 Biological: Placebo comparator |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Maternal Immunization To Prevent Infant Otitis Media |
Enrollment: | 153 |
Study Start Date: | October 2000 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Group 1 (experimental)
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Biological: PNCRM9
0.5 mL IM at 30-35 wks gestation
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Group 2: Placebo Comparator
Group 2 (placebo comparator)
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Biological: Placebo comparator
Sucrose cake (NaCl and sucrose) in aluminum phosphate adjuvant diluent at 0.5 mg per 0.5 mL dose IM at 30-35 wks gestation
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There were 24.5 million physician visits for otitis media (OM) in 1990 with estimated treatment and indirect costs of $5 billion. Because of its major public health impact and the troubling increase in antibiotic resistant organisms, vaccine strategies to prevent OM are being tested. We previously proposed an efficacy study to determine if immunization with pneumococcal vaccine during pregnancy protects offspring against early infant OM, which is an important predictor for recurrent and chronic OM. Recent data from an efficacy trial in California demonstrated that infants immunized with 7-valent pneumococcal conjugate vaccine (PNCRM7) at 2, 4, 6 and 12 - 15 months were protected against invasive pneumococcal disease after 7 months of age. Since licensure of this vaccine, questions have been raised about whether maternal immunization with a pneumococcal vaccine during pregnancy suppresses active antibody production in offspring who are immunized with 7-valent pneumococcal conjugate vaccine (PNCRM7). The main objective of this study is to investigate that question. We will also evaluate vaccine safety, immunogenicity, and fetal antibody transfer among women who receive 9-valent pneumococcal conjugate vaccine (PNCRM9) at 30 - 35 weeks of pregnancy, determine persistence of maternal and infant antibody 13 months after birth, evaluate opsonic activity of maternal and infant antibody, and determine the relationship between breast milk and serum antibody in lactating women.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Maternal inclusion criteria:
Infant inclusion criteria:
Exclusion Criteria:
Maternal exclusion criteria:
Infant exclusion criteria:
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
HealthPartners Research Foundation | |
Bloomington, Minnesota, United States, 55440 |
Principal Investigator: | Patricia Ferrieri | University of Minnesota |
Responsible Party: | DMID, NIAID, NIH ( George Curlin, Medical Officer ) |
Study ID Numbers: | R01DC005974-03 |
Study First Received: | February 14, 2008 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00617682 |
Health Authority: | United States: Food and Drug Administration |
Maternal immunization Pneumococcal conjugate vaccine Otitis media |
Otorhinolaryngologic Diseases Otitis Otitis Media Aluminum phosphate Ear Diseases |