- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01960725
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
10 mars 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
66
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Health System
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 veckor till 2 månader (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Standard Dosing Group
Group will receive RV5 vaccine at 2, 4, and 6 months of age
|
Andra namn:
|
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Experimentell: Alternate Dosing Group
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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G1 Serum-neutralizing Antibody
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
G2 Serum-neutralizing Antibody
Tidsram: 1 month following vaccine series completion
|
Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
|
1 month following vaccine series completion
|
|
G3 Serum-neutralizing Antibody
Tidsram: 1 month following vaccine series completion
|
Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
|
1 month following vaccine series completion
|
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G4 Serum-neutralizing Antibody
Tidsram: 1 month following vaccine series completion
|
Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
|
1 month following vaccine series completion
|
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P1 Serum-neutralizing Antibody
Tidsram: 1 month following vaccine series completion
|
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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Rotavirus Immunoglobulin A
Tidsram: 1 month following vaccine series completion
|
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
Tidsram: 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
Tidsram: 28 days after each dose, up to 10 months post-vaccination
|
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
|
28 days after each dose, up to 10 months post-vaccination
|
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Serious Adverse Event Assessment
Tidsram: After each dose and up to 10 months post-vaccination
|
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
|
After each dose and up to 10 months post-vaccination
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Dennis A Clements, MD, PhD, Duke University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2014
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 maj 2016
Studieregistreringsdatum
Först inskickad
7 oktober 2013
Först inskickad som uppfyllde QC-kriterierna
9 oktober 2013
Första postat (Uppskatta)
11 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00049081
- MISP-50891 (Annat bidrag/finansieringsnummer: Merck Investigator Studies Program)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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