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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Rini Mulia Sari, MD
- Telefoonnummer: 14102 +622033755
- E-mail: rini.mulia@biofarma.co.id
Studie Contact Back-up
- Naam: Mita Puspita, MD
- Telefoonnummer: 5045 +622033755
- E-mail: mita.puspita@biofarma.co.id
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Actieve vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rodman Tarigan Girsang, MD, Faculty of Medicine, Padjadjaran University, Bandung
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HepB0226
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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