- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00368966
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
6 juillet 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
619
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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A Coruna, Espagne, 15006
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Almeria, Espagne, 04120
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Almeria, Espagne, 04009
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Almeria, Espagne, 04007
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Barcelona, Espagne, 08025
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Barcelona, Espagne, 08017
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La Coruna, Espagne, 15270
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Madrid, Espagne, 28041
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Madrid, Espagne, 28021
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Malaga, Espagne, 29015
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Ourense, Espagne, 32005
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Sevilla, Espagne, 41013
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Valencia, Espagne, 46008
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Valencia, Espagne, 46011
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Valencia, Espagne, 46021
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Valencia, Espagne, 46022
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Valencia, Espagne, 46023
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Valencia, Espagne, 46024
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Valencia, Espagne, 46200
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Valencia, Espagne, 46013
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A Coruna
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Ferrol, A Coruna, Espagne, 15405
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Santiago de Compostela, A Coruna, Espagne, 15706
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Barcelona
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Argentona, Barcelona, Espagne, 08310
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Sabadell, Barcelona, Espagne, 08208
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Sant Adria de Besos, Barcelona, Espagne, 08930
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Sant Cugat del Valles, Barcelona, Espagne, 08195
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Sant Cugat del Valles, Barcelona, Espagne, 08197
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Bizkaia
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Bilbao, Bizkaia, Espagne, 48013
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Lugo
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Burela, Lugo, Espagne, 27880
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Madrid
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Alcorcon, Madrid, Espagne, 28922
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Fuenlabrada, Madrid, Espagne, 28943
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Getafe, Madrid, Espagne, 28902
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Getafe, Madrid, Espagne, 28900
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Mostoles, Madrid, Espagne, 28937
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Parla, Madrid, Espagne, 28980
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Malaga
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Antequera, Malaga, Espagne, 29200
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Navarra
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Pamplona, Navarra, Espagne, 31008
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Pontevedra
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Vigo, Pontevedra, Espagne, 36204
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Valencia
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Burjassot, Valencia, Espagne, 46110
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La Eliana, Valencia, Espagne, 46183
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Quart de Poblet, Valencia, Espagne, 46930
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 mois à 3 mois (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1
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Comparateur actif: 2
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Trial Manager, For Spain, infomed@wyeth.com
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2006
Achèvement primaire (Réel)
1 juillet 2008
Achèvement de l'étude (Réel)
1 juillet 2008
Dates d'inscription aux études
Première soumission
25 août 2006
Première soumission répondant aux critères de contrôle qualité
25 août 2006
Première publication (Estimation)
29 août 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 août 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2012
Dernière vérification
1 juillet 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6096A1-501
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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