Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Rini Mulia Sari, MD
- Telefonnummer: 14102 +622033755
- E-post: rini.mulia@biofarma.co.id
Studera Kontakt Backup
- Namn: Mita Puspita, MD
- Telefonnummer: 5045 +622033755
- E-post: mita.puspita@biofarma.co.id
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Exclusion Criteria:
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
- Infants with HbsAg and HIV positive (from cord blood)
- Mother suspected of immunodeficiency disease based on anamnesis
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Hep B vaccine in-house
0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
|
Aktiv komparator: Registered Hep B vaccine
0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
Tidsram: 28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
Percentage of subjects with anti HBsAg > 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group |
28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
Tidsram: 28 days after administration of Hep B birth dose vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine |
28 days after administration of Hep B birth dose vaccine
|
|
Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Tidsram: 28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine |
28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
|
Safety of In-House Recombinant Hepatitis B vaccine
Tidsram: 30 minutes, 7 days, 28 days after each dose
|
Percentage of subjects with solicited and unsolicited adverse events after each dose |
30 minutes, 7 days, 28 days after each dose
|
|
Serious Adverse Events
Tidsram: 28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
Percentage of infants with at least one serious adverse events |
28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Rodman Tarigan Girsang, MD, Faculty of Medicine, Padjadjaran University, Bandung
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HepB0226
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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