Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines
26. august 2010 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
MMR and Varicella Vaccine Responses in Extremely Premature Infants
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term.
A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term.
A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.
Extremely premature infants (born at <28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants.
We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at <29 weeks gestation.
This is a phase IV, observational study with 2 study arms having 16 infants each.
The first group will enroll infants 9-12 months old that were born premature (<29 weeks gestation).
The second group will be matched for sex, race, and postnatal age, but will have been full term (>= 37 weeks gestation) at birth.
Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).
Undersøgelsestype
Observationel
Tilmelding
32
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester School of Medicine and Dentistry
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 1 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Premature infant < 29 weeks gestation at birth or term infant >= 37 weeks gestation at birth.
- Postnatal age < 16 months, 0 days.
- Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
- Parental permission.
- Agreement of primary care pediatrician/ health care provider.
- Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
- Healthy status at enrollment.
Exclusion Criteria:
- Known immunodeficiency.
- Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- Requiring oxygen therapy.
- Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2004
Studieafslutning
1. juni 2005
Datoer for studieregistrering
Først indsendt
26. august 2005
Først indsendt, der opfyldte QC-kriterier
26. august 2005
Først opslået (Skøn)
30. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. august 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2010
Sidst verificeret
1. maj 2005
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- DNA-virusinfektioner
- Morbillivirus infektioner
- Paramyxoviridae infektioner
- Mononegavirales infektioner
- Herpesviridae infektioner
- Varicella Zoster Virus Infektion
- Togaviridae infektioner
- Rubivirus infektioner
- Mæslinger
- Herpes zoster
- Skoldkopper
- Røde hunde
Andre undersøgelses-id-numre
- 03-140
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