Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
17. januar 2013 opdateret af: Pfizer
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
666
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
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Jonesboro, Arkansas, Forenede Stater, 72401
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Downey, California, Forenede Stater, 90242
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Fontana, California, Forenede Stater, 92335
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Loma Linda, California, Forenede Stater, 92354
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Paramount, California, Forenede Stater, 90723
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Riverside, California, Forenede Stater, 92505
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
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Connecticut
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Norwich, Connecticut, Forenede Stater, 06360
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Florida
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Tampa, Florida, Forenede Stater, 33606
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Georgia
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Marietta, Georgia, Forenede Stater, 30062
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Woodstock, Georgia, Forenede Stater, 30189
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
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Park Ridge, Illinois, Forenede Stater, 60068
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Kansas
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Overland Park, Kansas, Forenede Stater, 66212
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
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Louisville, Kentucky, Forenede Stater, 40202
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Louisville, Kentucky, Forenede Stater, 40207
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New York
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Bronx, New York, Forenede Stater, 10467
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Rochester, New York, Forenede Stater, 14620
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245
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Cleveland, Ohio, Forenede Stater, 44118
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Mason, Ohio, Forenede Stater, 45040
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Pennsylvania
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Latrobe, Pennsylvania, Forenede Stater, 15650
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Pittsburg, Pennsylvania, Forenede Stater, 15241
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Pittsburgh, Pennsylvania, Forenede Stater, 15236
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Pittsburgh, Pennsylvania, Forenede Stater, 15227
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Sellersville, Pennsylvania, Forenede Stater, 18960
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Wexford, Pennsylvania, Forenede Stater, 15090
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38305
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Texas
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The Woodlands, Texas, Forenede Stater, 77380
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Utah
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Murray, Utah, Forenede Stater, 84107
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Provo, Utah, Forenede Stater, 84604
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Virginia
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Richmond, Virginia, Forenede Stater, 23219
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Vienna, Virginia, Forenede Stater, 22180
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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:
- Healthy 2-month-old infants.
- Available for the entire study period.
Exclusion criteria:
- Previous vaccination with any vaccine before the start of the study.
- Known contraindication to vaccination.
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 |
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Eksperimentel: 13vPnC vaccine
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1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
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Aktiv komparator: 7vPnC vaccine
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1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Tidsramme: One month after the 3-dose infant series (7 months of age)
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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.
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One month after the 3-dose infant series (7 months of age)
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Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Tidsramme: 1 Month After the Toddler Dose
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Antibody concentration/geometric mean concentration 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.
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1 Month After the Toddler Dose
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Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Tidsramme: One Month After the Infant Series (7 months of age)
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Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).
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One Month After the Infant Series (7 months of age)
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Percentage of Participants Reporting Pre-specified Systemic Events
Tidsramme: Within 7 days after each dose
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Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.)
appetite, irritability, increased (incr.)
sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 7 days after each dose
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Percentage of Participants Reporting Pre-specified Local Reactions
Tidsramme: Within 7 days after each dose
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant ([Sig.],
present and interfered with limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.],
2.5 to 7.0 cm); Severe ([Sev.],
> 7.0 cm).
Participants may have been represented in more than 1 category.
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Within 7 days after each dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Tidsramme: One month after toddler dose (13 to 16 months of age)
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One month after toddler dose (13 to 16 months of age)
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Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Tidsramme: one month after the toddler dose
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one month after the toddler dose
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Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Tidsramme: one month after the toddler dose
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Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
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one month after the toddler dose
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Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Tidsramme: one month after the toddler dose
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one month after the toddler dose
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Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Tidsramme: One month after infant series and one month after toddler dose
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Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.
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One month after infant series and one month after toddler dose
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Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Tidsramme: one month after the infant series and the toddler dose
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Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
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one month after the infant series and the toddler dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
- Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.
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. september 2006
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
7. september 2006
Først indsendt, der opfyldte QC-kriterier
7. september 2006
Først opslået (Skøn)
8. september 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6096A1-004
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 .