- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00370227
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
To Assess Safety, Reactogenicity & Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine, Co-admin With GSK Biologicals' MMRV Vaccine in Children (2nd yr of Life) Primed With the Pneumococcal Conjugate Vaccine in Study 105553.
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age.
The study has 3 groups.
- The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of MMRV vaccine at 14-16 mo of age.
- The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of MMRV vaccine at 14-16 mo of age.
- The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Helsinki, Finnland, 00930
- GSK Investigational Site
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Jarvenpaa, Finnland, 04400
- GSK Investigational Site
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Oulu, Finnland, 90100
- GSK Investigational Site
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Pori, Finnland, 28120
- GSK Investigational Site
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Tampere, Finnland, 33100
- GSK Investigational Site
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Turku, Finnland, 20520
- GSK Investigational Site
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Vantaa, Finnland, 01300
- GSK Investigational Site
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Vantaa, Finnland, 01600
- GSK Investigational Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
Exclusion Criteria:
- use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
- Administration of any additional pneumococcal vaccine since end of study 105553.
- Previous vaccination against measles, mumps, rubella and/or varicella. History of, or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
- Immunosuppressive or immunodeficient condition.
- A history of seizures or neurological disease.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Post vacc: rectal fever >39°C
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens.
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Vesikari T, Karvonen A, Lindblad N, Korhonen T, Lommel P, Willems P, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with measles-mumps-rubella-varicella vaccine in children aged 12 to 16 months. Pediatr Infect Dis J. 2010 Jun;29(6):e47-56. doi: 10.1097/INF.0b013e3181dffabf.
- Vesikari T et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) booster co-administered with MMRV vaccine in children aged 12-18 months. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
- Vesikari T et al. Immunogenicity and safety of a Measles-Mumps-Rubella-Varicella (MMRV) vaccine co-administered with pediatric vaccines in children aged 11-14 months. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 107706
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Studiendaten/Dokumente
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Einzelner Teilnehmerdatensatz
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einwilligungserklärung
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 107706Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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