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An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

10. mars 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

66

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Health System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 uker til 2 måneder (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
  2. Parent / legal guardian has read and signed the informed consent document
  3. Child and parent / legal guardian is available for the entire study period and can be reached by telephone
  4. Healthy infant as determined by medical history and by a baseline physical examination
  5. Infant weight at time of enrollment must exceed birth weight

Exclusion Criteria:

  1. History of hypersensitivity to the vaccine or any component of the vaccine
  2. History of Severe Combined Immunodeficiency Disease (SCID)
  3. History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
  4. History of intussusception
  5. 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
  6. Prior receipt of a rotavirus vaccine
  7. Less than 37 weeks gestation
  8. 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
  9. Receipt of blood products within 4 weeks of study vaccination
  10. 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.
  11. 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).
  12. Insufficient weight gain requiring future weight checks in addition to routine scheduled well child visits
  13. 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.
  14. Household contact who is immunodeficient (any malignancies or otherwise immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard Dosing Group
Group will receive RV5 vaccine at 2, 4, and 6 months of age
Andre navn:
  • RotaTeq
Eksperimentell: Alternate Dosing Group
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
Andre navn:
  • RotaTeq

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
G1 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
1 month following vaccine series completion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
G2 Serum-neutralizing Antibody
Tidsramme: 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
Tidsramme: 1 month following vaccine series completion
Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
1 month following vaccine series completion
G4 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
1 month following vaccine series completion
P1 Serum-neutralizing Antibody
Tidsramme: 1 month following vaccine series completion
Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
1 month following vaccine series completion

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Rotavirus Immunoglobulin A
Tidsramme: 1 month following vaccine series completion
Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
1 month following vaccine series completion
Reactogenicity Assessment
Tidsramme: 7 days after each dose, up to 10 months post-vaccination
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
7 days after each dose, up to 10 months post-vaccination
Adverse Event Assessment
Tidsramme: 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
Serious Adverse Event Assessment
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Dennis A Clements, MD, PhD, Duke University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2014

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. mai 2016

Datoer for studieregistrering

Først innsendt

7. oktober 2013

Først innsendt som oppfylte QC-kriteriene

9. oktober 2013

Først lagt ut (Anslag)

11. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Pro00049081
  • MISP-50891 (Annet stipend/finansieringsnummer: Merck Investigator Studies Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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