Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
6 juli 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
269
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Krakow, Polen, 30-663
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Krakow, Polen, 31-442
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Lodz, Polen, 91-347
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Lodz, Polen, 93-338
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Lublin, Polen, 20-044
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Warszawa, Polen, 01-184
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Bydgoszcz
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Torun, Bydgoszcz, Polen, 87-100
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Krakow
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Siemianowice Slaskie, Krakow, Polen, 41-103
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Lublin
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Lubartowie, Lublin, Polen, 21-100
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 månad till 3 månader (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Aged 2 months (42 to 98 days) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria:
- Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae.
- Major known congenital malformation or serious chronic disorders.
- 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.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 1
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1 dose at 2,3,4 and 12 months of age
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Aktiv komparator: 2
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1 dose at 2,3,4 and 12 months of age
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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.
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One month after 3-dose infant series (5 months of age)
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Percentage of Participants Reporting Pre-Specified Local Reactions
Tidsram: During the 4-day period 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).
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.
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During the 4-day period after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Tidsram: During the 4-day period after each dose
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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.
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During the 4-day period after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Tidsram: During the 4-day period after toddler dose
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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.
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During the 4-day period after toddler dose
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Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Tidsram: 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.
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One month after 3-dose infant series (5 months of age)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Trial Manager, For Poland, WPWZMED@wyeth.com
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2007
Primärt slutförande (Faktisk)
1 september 2008
Avslutad studie (Faktisk)
1 september 2008
Studieregistreringsdatum
Först inskickad
23 april 2007
Först inskickad som uppfyllde QC-kriterierna
23 april 2007
Första postat (Uppskatta)
24 april 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 augusti 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2012
Senast verifierad
1 juli 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 6096A1-3000
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .