- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00368966
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
6 juli 2012 bijgewerkt door: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
619
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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A Coruna, Spanje, 15006
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Almeria, Spanje, 04120
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Almeria, Spanje, 04009
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Almeria, Spanje, 04007
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Barcelona, Spanje, 08025
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Barcelona, Spanje, 08017
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La Coruna, Spanje, 15270
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Madrid, Spanje, 28041
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Madrid, Spanje, 28021
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Malaga, Spanje, 29015
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Ourense, Spanje, 32005
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Sevilla, Spanje, 41013
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Valencia, Spanje, 46008
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Valencia, Spanje, 46011
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Valencia, Spanje, 46021
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Valencia, Spanje, 46022
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Valencia, Spanje, 46023
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Valencia, Spanje, 46024
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Valencia, Spanje, 46200
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Valencia, Spanje, 46013
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A Coruna
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Ferrol, A Coruna, Spanje, 15405
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Santiago de Compostela, A Coruna, Spanje, 15706
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Barcelona
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Argentona, Barcelona, Spanje, 08310
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Sabadell, Barcelona, Spanje, 08208
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Sant Adria de Besos, Barcelona, Spanje, 08930
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Sant Cugat del Valles, Barcelona, Spanje, 08195
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Sant Cugat del Valles, Barcelona, Spanje, 08197
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Bizkaia
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Bilbao, Bizkaia, Spanje, 48013
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Lugo
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Burela, Lugo, Spanje, 27880
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Madrid
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Alcorcon, Madrid, Spanje, 28922
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Fuenlabrada, Madrid, Spanje, 28943
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Getafe, Madrid, Spanje, 28902
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Getafe, Madrid, Spanje, 28900
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Mostoles, Madrid, Spanje, 28937
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Parla, Madrid, Spanje, 28980
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Malaga
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Antequera, Malaga, Spanje, 29200
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Navarra
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Pamplona, Navarra, Spanje, 31008
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Pontevedra
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Vigo, Pontevedra, Spanje, 36204
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Valencia
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Burjassot, Valencia, Spanje, 46110
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La Eliana, Valencia, Spanje, 46183
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Quart de Poblet, Valencia, Spanje, 46930
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 maand tot 3 maanden (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
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Actieve vergelijker: 2
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Tijdsspanne: One month after 2-doses of the infant series (5 months of age)
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Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01
International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
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One month after 2-doses of the infant series (5 months of age)
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Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Tijdsspanne: One month after 2-doses of the infant series (5 months of age)
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One month after 2-doses of the infant series (5 months of age)
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Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Tijdsspanne: One month after 2-doses of the infant series (5 months of age)
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One month after 2-doses of the infant series (5 months of age)
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Percentage of Participants Reporting Pre-Specified Local Reactions
Tijdsspanne: During the 4-day period after each dose
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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.
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During the 4-day period after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events
Tijdsspanne: During the 4-day period after each dose
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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 [Med] 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.
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During the 4-day period after each dose
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Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Tijdsspanne: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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 dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tijdsspanne: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tijdsspanne: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tijdsspanne: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tijdsspanne: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Tijdsspanne: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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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, present in both 13vPnC and 7vPnC (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 dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Trial Manager, For Spain, infomed@wyeth.com
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
- Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2006
Primaire voltooiing (Werkelijk)
1 juli 2008
Studie voltooiing (Werkelijk)
1 juli 2008
Studieregistratiedata
Eerst ingediend
25 augustus 2006
Eerst ingediend dat voldeed aan de QC-criteria
25 augustus 2006
Eerst geplaatst (Schatting)
29 augustus 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
16 augustus 2012
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2012
Laatst geverifieerd
1 juli 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 6096A1-501
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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