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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00196976 |
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Meningococcal Serogroup Diseases |
Biological: Mencevax™ACWY Biological: Meningitec™ Biological: Conjugated meningococcal ACWY-TT (vaccine) Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Efficacy Study |
Official Title: | Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 m & 3-5 y |
Enrollment: | 461 |
Study Start Date: | March 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Experimental
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B
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Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
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Group A: Experimental
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A
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Biological: Mencevax™ACWY
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
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Group E: Active Comparator
Subjects of 12-14 months of age who will receive MenC-CRM197 and subjects of 3-5 years of age who will receive Mencevax™ ACWY
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Biological: Mencevax™ACWY
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Biological: Meningitec™
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
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Group D: Experimental
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D
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Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
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Group C: Experimental
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C
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Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
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The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation. The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
Ages Eligible for Study: | 12 Months to 60 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
For subjects aged 12-14 months at enrolment:
Austria | |
GSK Investigational Site | |
Wels, Austria, A-4600 | |
GSK Investigational Site | |
Salzburg, Austria, A-5020 | |
GSK Investigational Site | |
Villach, Austria, A-9500 | |
GSK Investigational Site | |
Eferding, Austria, A-4070 | |
GSK Investigational Site | |
Vienna, Austria, A-1020 | |
Greece | |
GSK Investigational Site | |
Ioannina, Greece, 452 21 | |
GSK Investigational Site | |
N. Efkarpia, Thessaloniki, Greece, 564 29 | |
GSK Investigational Site | |
Nea Makri, Greece, 19005 | |
GSK Investigational Site | |
Thessaloniki, Greece, 54636 | |
GSK Investigational Site | |
Koufalia, Greece, 571 00 | |
GSK Investigational Site | |
Athens, Greece, 11527 | |
GSK Investigational Site | |
Rio/Patras, Greece, 26500 | |
GSK Investigational Site | |
Tripolis, Greece, 22100 | |
GSK Investigational Site | |
Markopoulo, Greece, 19003 | |
GSK Investigational Site | |
Komotini, Greece, 69100 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 103533, 103534 (booster) |
Study First Received: | September 13, 2005 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00196976 History of Changes |
Health Authority: | Austria: BMGF, Bundesministerium für Gesundheit und Frauen |
Meningococcal vaccine Conjugate vaccine Immunogenicity Safety |
Reactogenicity Dose selection Toddlers Children |