- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00814710
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Kolkata, Indien, 700073
- GSK Investigational Site
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Ludhiana, Indien, 141 008
- GSK Investigational Site
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Pune, Indien
- GSK Investigational Site
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Vellore, Indien, 632004
- GSK Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (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) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Babies for which birth weight is < 2 kilogram.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
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Intramuskulær injektion, 3 doser
Intramuscular injection, 3 doses
Andre navne:
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Aktiv komparator: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
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Intramuscular injection, 3 doses
Andre navne:
Intramuscular injection, 3 doses
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Tidsramme: One month after primary immunization (month 3)
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Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after primary immunization (month 3)
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Concentration of Antibody Against Protein D (PD)
Tidsramme: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
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One month after primary immunization (month 3)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Tidsramme: One month after primary immunization (month 3)
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8. |
One month after primary immunization (month 3)
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Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Tidsramme: One month after primary immunization
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. The cut-off was defined as 0.20 microgram per milliliter (µg/mL). |
One month after primary immunization
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Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Tidsramme: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs in µg/mL.
Pneumococcal cross-reactive serotypes included 6A and 19A.
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One month after primary immunization (month 3)
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Number of Subjects Seropositive for Pneumococcal Serotypes
Tidsramme: One month after primary immunization (month 3)
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL |
One month after primary immunization (month 3)
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Number of Subjects Seropositive for Protein D (PD)
Tidsramme: One month after primary immunization (month 3)
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Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
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One month after primary immunization (month 3)
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Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Tidsramme: One month after primary immunization (month 3)
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Concentration is expressed as GMC in µg/mL.
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One month after primary immunization (month 3)
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Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Tidsramme: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
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One month after primary immunization (month 3)
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Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Tidsramme: One month after primary immunization (month 3)
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Concentration was expressed as GMC in EL.U/mL.
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One month after primary immunization (month 3)
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Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Tidsramme: One month after primary immunization (month 3)
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Concentration was expressed as GMC in milli international units per milliliter (mIU/mL).
As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
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One month after primary immunization (month 3)
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Number of Subjects Seropostive for B. Pertussis
Tidsramme: One month after primary immunization (month 3)
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Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
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One month after primary immunization (month 3)
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Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Tidsramme: One month after primary immunization (month 3)
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Seroprotection was defined as: Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL. |
One month after primary immunization (month 3)
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Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Tidsramme: One month after primary immunization (month 3)
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Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
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One month after primary immunization (month 3)
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Number of Subjects With Solicited Local and General Symptoms
Tidsramme: Within 4 days (day 0-3) after vaccination
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Solicited local symptoms included pain, redness and swelling.
Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
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Within 4 days (day 0-3) after vaccination
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Number of Subjects With Unsolicited Adverse Events (AEs)
Tidsramme: Within 31 days (day 0-30) after vaccination
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms |
Within 31 days (day 0-30) after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: Following first vaccination (Month 0) throughout the entire study period (month 3)
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SAEs assessed include 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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Following first vaccination (Month 0) throughout the entire study period (month 3)
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
- Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungebetændelse
- Lungesygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Lungebetændelse, bakteriel
- Pneumokokinfektioner
- Lungebetændelse, Pneumokok
- Streptokokinfektioner
- Lægemidlers fysiologiske virkninger
- Immunologiske faktorer
- Heptavalent pneumokokkonjugatvaccine
Andre undersøgelses-id-numre
- 111188
- 2011-004644-22 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Studiedata/dokumenter
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Studieprotokol
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoteret sagsbetænkningsformular
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informations-id: 111188Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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