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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

15. august 2013 oppdatert av: Sanofi Pasteur, a Sanofi Company

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

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2133

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Filippinene
      • Corporate City, Filippinene
        • Filinvest
    • Muntinlupa City
      • Alabang, Muntinlupa City, Filippinene
      • Putatan,, Muntinlupa City, Filippinene
      • Tunasan,, Muntinlupa City, Filippinene

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 måned til 1 måned (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: DTaP-HB-PRP~T combined vaccine
0.5 mL, Intramuscular
Biologisk: Oral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.
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.
Biologisk: Oral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.
Biologisk: Tritanrix-HepB/Hib™ vaccine
0.5 mL, Intramuscular

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 1 month post third vaccination

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
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.
Tidsramme: Day 0 to Day 7 post-vaccination
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Day 0 to Day 7 post-vaccination

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 1 month post third 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; 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.
1 month post third vaccination
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
Tidsramme: Day 0 to Day 7 after vaccination

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2006

Primær fullføring (Faktiske)

1. oktober 2007

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

5. juli 2006

Først innsendt som oppfylte QC-kriteriene

5. juli 2006

Først lagt ut (Anslag)

6. juli 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AL201

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