Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Meningococcal Meningitis Clinical Trial

Official title:

A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Meningitis

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