- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00617682
Maternal Immunization To Prevent Infant Otitis Media
14 februari 2008 bijgewerkt door: National Institute on Deafness and Other Communication Disorders (NIDCD)
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
153
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Minnesota
-
Bloomington, Minnesota, Verenigde Staten, 55440
- HealthPartners Research Foundation
-
Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Group 1
Group 1 (experimental)
|
0.5 mL IM at 30-35 wks gestation
|
Placebo-vergelijker: Group 2
Group 2 (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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Determine if offspring of women immunized with PNCRM9 or control during the third trimester have equivalent anticapsular polysaccharide (PS) IgG antibody responses to PNCRM7 measured 1 mo after the 3rd injection given at 6 mos of age.
Tijdsspanne: In infants at 7 months of age; In women at 1-7 days post-immunization
|
In infants at 7 months of age; In women at 1-7 days post-immunization
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Determine if offspring of these women have equivalent antibody responses to PNCRM7 at 13 mos. Sera are analyzed for anti-PS IgG, opsonic activity, IgG1 & IgG2 subclasses (14,6B,19F,23F), & antibodies against Hib-PRP & diphtheria toxoid.
Tijdsspanne: In infants at 13 months of age.
|
In infants at 13 months of age.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Patricia Ferrieri, University of Minnesota
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Le CT, Grambsch PM, Giebink GS. Quality control and the identification of vaccine responders using ELISA-derived antibody data. Stat Med. 2003 Sep 30;22(18):2935-42. doi: 10.1002/sim.1530.
- Daly KA, Toth JA, Giebink GS. Pneumococcal conjugate vaccines as maternal and infant immunogens: challenges of maternal recruitment. Vaccine. 2003 Jul 28;21(24):3473-8. doi: 10.1016/s0264-410x(03)00354-2.
- Daly KA, Scott Giebink G, Lindgren BR, Knox J, Haggerty BJ, Nordin J, Goetz S, Ferrieri P. Maternal immunization with pneumococcal 9-valent conjugate vaccine and early infant otitis media. Vaccine. 2014 Dec 5;32(51):6948-6955. doi: 10.1016/j.vaccine.2014.10.060. Epub 2014 Oct 30.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2000
Primaire voltooiing (Werkelijk)
1 december 2004
Studie voltooiing (Werkelijk)
1 december 2004
Studieregistratiedata
Eerst ingediend
14 februari 2008
Eerst ingediend dat voldeed aan de QC-criteria
14 februari 2008
Eerst geplaatst (Schatting)
18 februari 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
18 februari 2008
Laatste update ingediend die voldeed aan QC-criteria
14 februari 2008
Laatst geverifieerd
1 februari 2008
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R01DC005974-03 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Otitis media
-
David Chi, MDWervingTerugkerende acute otitis media | Chronische otitis media met effusie | Otitis media bij kinderenVerenigde Staten
-
Bezmialem Vakif UniversityVoltooid
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceVoltooidChronische sereuze otitis media, eenvoudig of niet gespecificeerdFrankrijk
-
Alcon ResearchVoltooidOtitis Media met effusie bij kinderen | Otitis media terugkerend
-
Tusker MedicalVoltooidAOM - Acute otitis media | OME - Otitis Media met effusieVerenigde Staten, Canada
-
Medical College of WisconsinNational Institutes of Health (NIH); National Institute on Deafness and Other... en andere medewerkersWervingOtitis media | Otitis Media met effusie | Otitis media acuutVerenigde Staten
-
Alcon ResearchVoltooidOtitis Media met effusie bij kinderen | Otitis media terugkerend
-
Mansoura UniversityVoltooidChronische etterige otitis mediaEgypte
-
Nationwide Children's HospitalIngetrokken
-
University Hospital, GhentIngetrokken
Klinische onderzoeken op PNCRM9
-
National Institute of Allergy and Infectious Diseases...Voltooid