Clinical trial NCT00667602: Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Official title: A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Toddlers
Infants
Concomitant Vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 662
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).


Eligibility criteria: Inclusion Criteria:

* infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry

Exclusion Criteria:

* who previously received any meningococcal vaccine;
* who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
* who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
* Subjects with any serious, acute or chronic progressive disease

Primary outcomes:
measure: Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination
Secondary outcomes:
measure: Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y
timeFrame: 1 month postvaccination.
measure: Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y
timeFrame: 1 month postvaccination.
measure: Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination
measure: Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y
timeFrame: 1 month postvaccination
measure: Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)
timeFrame: 1 month postvaccination
measure: Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C
timeFrame: 1 month postvaccination and 6-18 months postvaccination.
measure: Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y
timeFrame: 1 month postvaccination 6-18 months postvaccination
measure: Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination and 6-18 months postvaccination.
measure: Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y
timeFrame: 6-18 months postvaccination.
measure: Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination.
measure: Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y
timeFrame: 1 month postvaccination.
measure: Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C
timeFrame: 1 month postvaccination.
measure: Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y
timeFrame: 1 month postvaccination.
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination
timeFrame: From day 1 to day 7 postvaccination
Other outcomes:
Locations:
city: Bad Kreuznach
country: Germany
facility: Site 22
city: Bad Lobenstein
country: Germany
facility: Site 38
city: Balve
country: Germany
facility: Site 24
city: Berlin
country: Germany
facility: Site 3
city: Berlin
country: Germany
facility: Site 27
city: Berlin
country: Germany
facility: Site 20
city: Berlin
country: Germany
facility: Site 26
city: Berlin
country: Germany
facility: Site 13
city: Berlin
country: Germany
facility: Site 31
city: Berlin
country: Germany
facility: Site 25
city: Bönnigheim
country: Germany
facility: Site 15
city: Eschwege
country: Germany
facility: Site 39
city: Flensburg
country: Germany
facility: Site 32
city: Frankenthal
country: Germany
facility: Site 16
city: Glücksburg
country: Germany
facility: Site 33
city: Hamburg
country: Germany
facility: Site 35
city: Kehl
country: Germany
facility: Site 2
city: Mainz
country: Germany
facility: Site 28
city: Mainz
country: Germany
facility: Site 44
city: München-Ramersdorf
country: Germany
facility: Site 43
city: Neuhaus am Rennweg
country: Germany
facility: Site 42
city: Neumünster
country: Germany
facility: Site 21
city: Neumünster
country: Germany
facility: Site 9
city: Oberstenfeld
country: Germany
facility: Site 10
city: Stuttgart
country: Germany
facility: Site 4
city: Stuttgart
country: Germany
facility: Site 19
city: Weilheim i OB
country: Germany
facility: Site 30
city: Wiesloch
country: Germany
facility: Site 6
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.