- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01960725
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
10. marts 2017 opdateret af: Dennis Clements
An Open-label, Pilot Study to Compare the Safety and Immunogenicity of an Alternate Dosing Schedule (2-5 Weeks, 2 Months, and 4 Months) for Pentavalent Rotavirus Vaccine (RotaTeq) to the Standard Recommended Schedule (2, 4, and 6 Months)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months).
In this interventional, open-label study, infants 2 through 5 weeks of age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to the standard recommended schedule (2, 4, and 6 months of age).
Sera will be obtained from subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8] serotypes.
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the alternate dosing schedule versus the standard recommended schedule.
Likewise, post dose 3 G2, G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving RV5 according to the alternate dosing schedule and the standard recommended schedule.
The safety and tolerability of RV5 in children receiving vaccine according to the alternate dosing schedule will be described.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Health System
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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
2 uger til 2 måneder (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
- Parent / legal guardian has read and signed the informed consent document
- Child and parent / legal guardian is available for the entire study period and can be reached by telephone
- Healthy infant as determined by medical history and by a baseline physical examination
- Infant weight at time of enrollment must exceed birth weight
Exclusion Criteria:
- History of hypersensitivity to the vaccine or any component of the vaccine
- History of Severe Combined Immunodeficiency Disease (SCID)
- History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
- History of intussusception
- Any clinically significant history of gastrointestinal disease including active acute gastrointestinal illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, abdominal surgery or liver disease
- Prior receipt of a rotavirus vaccine
- Less than 37 weeks gestation
- The subject has participated in a study with an experimental agent within one month of enrollment in the study or anticipated receipt of an experimental agent during participation in the study
- Receipt of blood products within 4 weeks of study vaccination
- Receipt of a live virus vaccine within 4 weeks of study vaccination or an inactivated vaccine within 2 weeks. Concomitant administration of routinely recommended vaccines is allowed. A dose of hepatitis B vaccine administered in the birthing hospital is permitted. Planned routine use of inactivated influenza vaccine for children over 6 months of age is permitted.
- Acute illness within 48 hours of vaccination (axillary temperature of 100.4°F or higher, 3 or more grossly watery stools, vomiting). (Infants with stable unchanged gastroesophageal reflux may be enrolled).
- Insufficient weight gain requiring future weight checks in addition to routine scheduled well child visits
- The subject has any condition that the investigator believes would put the subject at an increased risk of injury or would render the subject unable to complete the trial or fulfill the requirements of the study protocol.
- Household contact who is immunodeficient (any malignancies or otherwise immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard Dosing Group
Group will receive RV5 vaccine at 2, 4, and 6 months of age
|
Andre navne:
|
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Eksperimentel: Alternate Dosing Group
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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G1 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
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Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
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1 month following vaccine series completion
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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G2 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
|
Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
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1 month following vaccine series completion
|
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G3 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
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Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
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1 month following vaccine series completion
|
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G4 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
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Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
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1 month following vaccine series completion
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P1 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
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Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
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1 month following vaccine series completion
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Serum Rotavirus Immunoglobulin A
Tidsramme: 1 month following vaccine series completion
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Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
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1 month following vaccine series completion
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Reactogenicity Assessment
Tidsramme: 7 days after each dose, up to 10 months post-vaccination
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Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined
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7 days after each dose, up to 10 months post-vaccination
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Adverse Event Assessment
Tidsramme: 28 days after each dose, up to 10 months post-vaccination
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Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
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28 days after each dose, up to 10 months post-vaccination
|
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Serious Adverse Event Assessment
Tidsramme: After each dose and up to 10 months post-vaccination
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Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
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After each dose and up to 10 months post-vaccination
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dennis A Clements, MD, PhD, Duke University
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. februar 2014
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. maj 2016
Datoer for studieregistrering
Først indsendt
7. oktober 2013
Først indsendt, der opfyldte QC-kriterier
9. oktober 2013
Først opslået (Skøn)
11. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00049081
- MISP-50891 (Andet bevillings-/finansieringsnummer: Merck Investigator Studies Program)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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