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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

6. juli 2012 oppdatert av: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

269

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Polen
      • Krakow, Polen, 30-663
      • Krakow, Polen, 31-442
      • Lodz, Polen, 91-347
      • Lodz, Polen, 93-338
      • Lublin, Polen, 20-044
      • Warszawa, Polen, 01-184
    • Bydgoszcz
      • Torun, Bydgoszcz, Polen, 87-100
    • Krakow
      • Siemianowice Slaskie, Krakow, Polen, 41-103
    • Lublin
      • Lubartowie, Lublin, Polen, 21-100

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 3 måneder (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  1. Aged 2 months (42 to 98 days) at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
  3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by S pneumoniae.
  7. Major known congenital malformation or serious chronic disorders.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
  9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.

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: 1
Biologisk: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
Aktiv komparator: 2
Biologisk: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Tidsramme: One month after 3-dose infant series (5 months of age)
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after 3-dose infant series (5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Tidsramme: During the 4-day period after each dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Tidsramme: During the 4-day period after each dose
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Tidsramme: During the 4-day period after toddler dose
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
During the 4-day period after toddler dose
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Tidsramme: One month after 3-dose infant series (5 months of age)
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after 3-dose infant series (5 months of age)

Samarbeidspartnere og etterforskere

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Etterforskere

  • Hovedetterforsker: Trial Manager, For Poland, WPWZMED@wyeth.com

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.

Generelle publikasjoner

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 2007

Primær fullføring (Faktiske)

1. september 2008

Studiet fullført (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

23. april 2007

Først innsendt som oppfylte QC-kriteriene

23. april 2007

Først lagt ut (Anslag)

24. april 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 6096A1-3000

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