- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04596696
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
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
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Hanoi, Vietnam
- Vietnam Military Medical University Hospital
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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
1 måned til 1 måned (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
- Healthy infants as established by medical history and clinical examination
- Age: 6-8 weeks
- Weight ≥2.5kgs at birth
- Infants receiving EPI vaccines as per Vietnam immunization program
- Parental ability and willingness to provide informed consent.
- Parent who intends to remain in the area with the participant during the study period.
Exclusion Criteria:
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (temporary exclusion).
- Concurrent participation in another clinical trial.
- 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.
- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Prior receipt of rotavirus vaccine.
- A known sensitivity or allergy to any components of the study vaccines.
- Major congenital or genetic defect.
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- 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.
- History of any neurologic disorders or seizures.
- 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 |
|---|---|
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Andet: Single arm Rotavac
Single arm Open Label study without comparator
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Demonstrate immunogenicity of 3-dose regimen of Rotavac
Tidsramme: At the end of 28 days after last dose
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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
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At the end of 28 days after last dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assess and compare reactogenicity and safety (adverse events)
Tidsramme: At the end of 28 days after last dose
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Reactogenicity and safety of Rotavac in terms of adverse event
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At the end of 28 days after last dose
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BBIL/ROTAVAC/Vietnam/2017
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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