- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01457560
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
- Healthy male and female subjects in the ≥12 and <16 weeks of life at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria:
The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
- Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of seizures or of any neurological disease at study entry.
- Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
- Acute disease at the time of enrolment.
Studieplan
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 |
---|---|
Eksperimentel: Gruppe A
|
Tre doser administreret intramuskulært
One dose administered orally
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Tidsramme: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
|
One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Tidsramme: Before the first dose ( Month 0 )
|
Before the first dose ( Month 0 )
|
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Tidsramme: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
|
Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
|
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Tidsramme: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
|
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
|
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Tidsramme: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
|
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
|
Number of subjects with solicited and unsolicited adverse events
Tidsramme: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
|
After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
|
Number of subjects with serious adverse events
Tidsramme: During the study period (Month 0 to Month 9)
|
During the study period (Month 0 to Month 9)
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Neuromuskulære sygdomme
- Infektioner i centralnervesystemet
- Hepatitis, viral, menneskelig
- Hepadnaviridae infektioner
- DNA-virusinfektioner
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Actinomycetales infektioner
- Enterovirus infektioner
- Picornaviridae infektioner
- Rygmarvssygdomme
- Corynebacterium infektioner
- Hepatitis
- Myelitis
- Hepatitis B
- Difteri
- Poliomyelitis
Andre undersøgelses-id-numre
- 217744/060
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
-
Formular til informeret samtykke
Informations-id: 217744/060Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: 217744/060Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Individuelt deltagerdatasæt
Informations-id: 217744/060Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasætspecifikation
Informations-id: 217744/060Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokol
Informations-id: 217744/060Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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