- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00911144
Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Ansan, Korean tasavalta, 425-707
- GSK Investigational Site
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Bucheon-Si, GyeongGi-do,, Korean tasavalta, 420-767
- GSK Investigational Site
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Daejeon, Korean tasavalta, 301-723
- GSK Investigational Site
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GyeongSangNam-do, Korean tasavalta, 641-560
- GSK Investigational Site
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Gyeonggi-do, Korean tasavalta, 411-706
- GSK Investigational Site
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Iksan, Korean tasavalta, 570-711
- GSK Investigational Site
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Jeju City, Korean tasavalta, 690-121
- GSK Investigational Site
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Jeonju Jeonbuk, Korean tasavalta, 561-712
- GSK Investigational Site
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Pusan, Korean tasavalta, 602-739
- GSK Investigational Site
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Seoul, Korean tasavalta, 150-719
- GSK Investigational Site
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Seoul, Korean tasavalta, 130-702
- GSK Investigational Site
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Seoul, Korean tasavalta, 158-710
- GSK Investigational Site
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Suwon City, Gyeonggi-do, Korean tasavalta, 442-723
- GSK Investigational Site
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Wonju-si Kangwon-do, Korean tasavalta, 220-701
- GSK Investigational Site
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- A male or female between, and including, 12-18 months of age at the time of booster vaccination.
- Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
- Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
- Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- Acute disease at the time of enrolment.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
Muut nimet:
Intramuscular injection, administered as a single dose
Muut nimet:
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Active Comparator: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
Muut nimet:
Intramuscular injection, administered as a single dose
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Subjects Reporting Grade 3 Adverse Events
Aikaikkuna: Within 31 days (Day 0 - Day 30) after booster vaccination.
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Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
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Within 31 days (Day 0 - Day 30) after booster vaccination.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Subjects Reporting Solicited Symptoms
Aikaikkuna: Within 4 days (Days 0 to 3) after booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
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Within 4 days (Days 0 to 3) after booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events
Aikaikkuna: Within 31 days (Days 0 to 30) after booster vaccination
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study.
Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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Within 31 days (Days 0 to 30) after booster vaccination
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Number of Subjects Reporting Serious Adverse Events
Aikaikkuna: After booster vaccination up to study end (Month 0 to Month 1)
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Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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After booster vaccination up to study end (Month 0 to Month 1)
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Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Aikaikkuna: One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Aikaikkuna: One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Aikaikkuna: One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Aikaikkuna: One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Protein D (PD)
Aikaikkuna: One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Aikaikkuna: One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
- Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
- Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
- Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 112933
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Tutkimustiedot/asiakirjat
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Ilmoitettu suostumuslomake
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tietojoukon määritys
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tutkimuspöytäkirja
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tilastollinen analyysisuunnitelma
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Kliinisen tutkimuksen raportti
Tiedon tunniste: 112933Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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