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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

6. juli 2012 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Polen
      • Bydgoszcz, Polen, 85-168
      • Debica, Polen, 39-200
      • Krakow, Polen, 31-202
      • Krakow, Polen, 30-663
      • Krakow, Polen, 31-422
      • Lodz, Polen, 91-347
      • Lubartow, Polen, 21-100
      • Lublin, Polen, 20-044
      • Oborniki Slaskie, Polen, 55-120
      • Poznan, Polen, 60-535
      • Poznan, Polen, 61-709
      • Siemianowice Slaskie, Polen, 41-103
      • Torun, Polen, 87-100
      • Trzebnica, Polen, 55-100

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 3 måneder (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

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

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae.
  8. Major known congenital malformation or serious chronic disorder.
  9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
  10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Biologisk: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Aktiv komparator: 2
Biologisk: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Tidsramme: One month after 3-dose infant series (at 5 months of age)
Percentages of participants achieving World Health Organization (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 (at 5 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Tidsramme: One month after 3-dose infant series (at 5 months of age)
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 (at 5 months of age)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Tidsramme: one month after the toddler dose (at 13 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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 the toddler dose (at 13 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Tidsramme: one month after the toddler dose (at 13 months of age)
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 the toddler dose (at 13 months of age)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of Participants Reporting Pre-Specified Local Reactions
Tidsramme: Within 4-days after each dose
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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.
Within 4-days after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Tidsramme: Within 4-days after each dose
Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4-days after each dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2006

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

17. august 2006

Først indsendt, der opfyldte QC-kriterier

18. august 2006

Først opslået (Skøn)

21. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 6096A1-009

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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