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Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

21. oktober 2020 opdateret af: Bharat Biotech International Limited

An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

  • The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety.
  • Active surveillance will be conducted for all participants for 14 & 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity")
  • Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI)
  • Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

360

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Hanoi, Vietnam
        • Vietnam Military Medical University Hospital

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

1 måned til 1 måned (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  1. Healthy infants as established by medical history and clinical examination
  2. Age: 6-8 weeks
  3. Weight ≥2.5kgs at birth
  4. Infants receiving EPI vaccines as per Vietnam immunization program
  5. Parental ability and willingness to provide informed consent.
  6. Parent who intends to remain in the area with the participant during the study period.

Exclusion Criteria:

  1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
  2. Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (temporary exclusion).
  3. Concurrent participation in another clinical trial.
  4. Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immuno-logical, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
  5. History of congenital abdominal disorders, intussusception, abdominal surgery
  6. Known or suspected impairment of immunological function based on medical history and physical examination.
  7. Prior receipt of rotavirus vaccine.
  8. A known sensitivity or allergy to any components of the study vaccines.
  9. Major congenital or genetic defect.
  10. Participant's parents not able, available or willing to accept active follow-up by the study staff.
  11. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
  12. History of chronic administration (defined as more than 14 days) of immunosuppressant including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
  13. History of any neurologic disorders or seizures.
  14. Any medical condition in the parents/ infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Single arm Rotavac
Single arm Open Label study without comparator
Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P[11], containing one bovine rotavirus gene P[11] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Demonstrate immunogenicity of 3-dose regimen of Rotavac
Tidsramme: At the end of 28 days after last dose
Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose
At the end of 28 days after last dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess and compare reactogenicity and safety (adverse events)
Tidsramme: At the end of 28 days after last dose
Reactogenicity and safety of Rotavac in terms of adverse event
At the end of 28 days after last dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Dr Krishana Mohan, MD, Bharat Biotech International Limited

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 (Faktiske)

20. december 2017

Primær færdiggørelse (Faktiske)

30. december 2018

Studieafslutning (Faktiske)

30. juni 2019

Datoer for studieregistrering

Først indsendt

14. maj 2018

Først indsendt, der opfyldte QC-kriterier

20. oktober 2020

Først opslået (Faktiske)

22. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BBIL/ROTAVAC/Vietnam/2017

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rotavirus Gastroenteritis

Kliniske forsøg med Rotavac

Abonner