- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00348881
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Corporate City, Filippinerna
- Filinvest
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Muntinlupa City
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Alabang, Muntinlupa City, Filippinerna
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Putatan,, Muntinlupa City, Filippinerna
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Tunasan,, Muntinlupa City, Filippinerna
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
At Screening:
- 0 to 3 day old infants
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score ≥ 7 at three minutes after birth
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
At Inclusion:
- Six weeks of age
- Received a dose of Hepatitis B (HB) in the first three days of life
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
At Screening:
- Illness at a stage that could interfere with trial conduct or completion
- Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
- Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
- Acute illness on the day of screening.
At Screening and at Inclusion:
- Blood or blood-derived products received since birth
- Planned participation in another clinical trial during the present trial period
- Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
At Inclusion:
- Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
- Participation in another clinical trial before the first trial vaccination
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
- Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
- History of seizures
- Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
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0.5 mL, Intramuscular
Oral co-administered with study vaccine.
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Aktiv komparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
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Oral co-administered with study vaccine.
0.5 mL, Intramuscular
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Tidsram: 1 month post third vaccination
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Seroprotection 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. Seroprotection was 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 at 30 days after the third vaccination. |
1 month post third vaccination
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Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Tidsram: Day 0 to Day 7 post-vaccination
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Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
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Day 0 to Day 7 post-vaccination
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Tidsram: 1 month post third vaccination
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Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
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1 month post third vaccination
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Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Tidsram: Day 0 to Day 7 after vaccination
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Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (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 ≥ 39.6ºC; 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 to Day 7 after vaccination
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Hepatit, Viral, Human
- Hepadnaviridae-infektioner
- DNA-virusinfektioner
- Bordetella infektioner
- Gram-negativa bakteriella infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-positiva bakteriella infektioner
- Actinomycetales infektioner
- Clostridium infektioner
- Corynebacterium-infektioner
- Hepatit B
- Kikhosta
- Hepatit
- Stelkramp
- Difteri
- Läkemedels fysiologiska effekter
- Immunologiska faktorer
- Vacciner
Andra studie-ID-nummer
- AL201
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