- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00514709
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.
Primary Objectives:
- To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
- To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.
Secondary Objective:
- To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
-
-
Alabang
-
Muntinlupa City, Alabang, Filippijnen
-
-
Alabang Junction Alabang
-
Muntinlupa City, Alabang Junction Alabang, Filippijnen
-
-
Bayanan Annex
-
Muntinlupa City, Bayanan Annex, Filippijnen
-
-
Cupang
-
Muntinlupa City, Cupang, Filippijnen
-
-
Filinvest
-
Muntinlupa City, Filinvest, Filippijnen
-
-
Putatan
-
Muntinlupa City, Putatan, Filippijnen
-
-
Tunasan
-
Muntinlupa City, Tunasan, Filippijnen
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
- Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the last 3 months
- Any vaccination in the 4 weeks preceding the trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
- History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
- Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series
- Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- Serious adverse event related to any vaccination in the AL201 study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Groep 1
DTaP-Hep B-PRP-T + OPV-vaccingroep
|
0.5 mL, Intramuscular (IM)
Oral co-administered with study vaccine.
|
Experimenteel: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
|
Oral co-administered with study vaccine.
0.5 mL, IM
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Tijdsspanne: Day 0 (pre-vaccination) and Day 28 post-booster vaccination
|
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response. |
Day 0 (pre-vaccination) and Day 28 post-booster vaccination
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Tijdsspanne: Day 0 (pre-vaccination) and Day 28 post-vaccination
|
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
|
Day 0 (pre-vaccination) and Day 28 post-vaccination
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Tijdsspanne: Day 0 up to Day 7 after vaccination
|
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. |
Day 0 up to Day 7 after vaccination
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Hepadnaviridae-infecties
- DNA-virusinfecties
- Bordetella-infecties
- Gram-negatieve bacteriële infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-positieve bacteriële infecties
- Actinomycetales-infecties
- Enterovirusinfecties
- Picornaviridae-infecties
- Clostridium-infecties
- Corynebacterium-infecties
- Hepatitis B
- Kinkhoest
- Hepatitis
- Hepatitis A
- Tetanus
- Difterie
- Fysiologische effecten van medicijnen
- Immunologische factoren
- Vaccins
Andere studie-ID-nummers
- AL204
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hepatitis B
-
Brii Biosciences LimitedVir Biotechnology, Inc.Actief, niet wervendChronische hepatitis B-virusinfectieSingapore, Thailand, Australië, China, Korea, republiek van
-
Mahidol UniversityOnbekendChronische hepatitis B, HBsAg, hepatitis B-vaccinThailand
-
Tasly Tianjin Biopharmaceutical Co., Ltd.Onbekend
-
Zhongshan Hospital Xiamen UniversityOnbekendGezond | Chronische hepatitis B-infectieChina
-
Tasly Tianjin Biopharmaceutical Co., Ltd.VoltooidHepatitis B-virus (HBV)China
-
National Taiwan University HospitalPharmaEssentiaWervingChronische hepatitis B-virusinfectieTaiwan
-
Bristol-Myers SquibbVoltooidChronisch hepatitis B-virus, pediatrischVerenigde Staten, Korea, republiek van, Taiwan, Verenigd Koninkrijk, België, Canada, Russische Federatie, Argentinië, Duitsland, Griekenland, Indië, Israël, Polen, Roemenië
-
University Hospital, Strasbourg, FranceWerving
-
Bristol-Myers SquibbVoltooidChronisch hepatitis B-virus
-
Hannover Medical SchoolGerman Center for Infection ResearchWerving
Klinische onderzoeken op DTaP-HB PRP~T Combined Vaccine
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Difterie | PolioKalkoen
-
Sanofi Pasteur, a Sanofi CompanyVoltooidKinkhoest | Tetanus | Difterie | Poliomyelitis | Haemophilus Influenzae type bArgentinië
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | PoliomyelitisMexico
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Difterie | PolioKalkoen
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | Haemophilus Influenzae type bPeru, Mexico
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | PoliomyelitisColombia, Costa Rica
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | Poliomyelitis | Haemophilus Influenzae Type B-infectieMexico
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | Haemophilus Influenzae type bFilippijnen
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Tetanus | Difterie | Haemophilus-infectiesFilippijnen
-
Sanofi Pasteur, a Sanofi CompanyVoltooidHepatitis B | Kinkhoest | Difterie | Polio | Haemophilus Influenzae type bZuid-Afrika