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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00310817
Other study ID # V59P7
Secondary ID EUDRACT NUMBER:
Status Completed
Phase Phase 2
First received April 3, 2006
Last updated October 6, 2015
Start date March 2005
Est. completion date May 2006

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFinland: Finnish Medicines AgencyPoland: CEBK (Central Register of Clinical Trials)
Study type Interventional

Clinical Trial Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine


Recruitment information / eligibility

Status Completed
Enrollment 623
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 59 Months
Eligibility Inclusion Criteria:

- healthy 12-<60 month old children;

Exclusion Criteria:

- subjects who have previously received any meningococcal vaccine

- subjects with any serious acute or chronic progressive disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Biological:
MenACWY-CRM conjugate vaccine, adjuvanted

MenACWY polysaccharide vaccine

MenACWY-CRM conjugate vaccine, unadjuvanted


Locations

Country Name City State
Finland University of Tampere Medical School Tampere
Poland Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow Samodzielny ZOZ, Lubartów

Sponsors (2)

Lead Sponsor Collaborator
Novartis Vaccines Novartis

Countries where clinical trial is conducted

Finland,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers = 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination. No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination No
Secondary hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination No
Secondary hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary Percentage of Subjects With hSBA Titers = 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 21 days after the second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination. No
Secondary hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 28 days after first vaccination. No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 6 months after first vaccination and 12 months after first vaccination No
Secondary hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 21 days after the second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 21 days after second vaccination No
Secondary hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. 12 months after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers = 1:4 against N. meningitidis serogroups A, C, W, and Y. 12 months after second vaccination No
Secondary Percentages of Subjects With hSBA Titers = 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers = 1:8 against N. meningitidis serogroups A, C, W, and Y. 12 months after second vaccination No
Secondary Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. From day 1 through day 7 after first or second vaccination(s) Yes
Secondary Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study. 28 days after first vaccination and 21 days after second vaccination Yes
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