Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers - Full Text View

Purpose

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 ≥ 8 obtained in the serum bactericidal assay using human complement (hSBA).

Condition	Intervention	Phase
Meningococcal Meningitis	Biological: MenACWY Biological: Routine Vaccines Biological: MenC	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

Drug Information available for: Lactitol Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity of one dose of MenACWY to one dose of Menjugate one month post vaccination. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity of two doses of MenACWY to one dose of MenC as measured as measured by hSBA GMTs, percentage of subjects with hSBA titers ≥ 1:8 and hSBA-titers ≥ 1:4, directed against N. meningitidis serogroup C. [ Time Frame: 1 month post vaccination at 12 months of age ] [ Designated as safety issue: No ]
Persistence of immune response to either one or two doses of MenACWY or one dose of MenC as measured by hSBA GMTs and percentage of subjects with hSBA titers ≥ 1:8 and hSBA titers ≥ 1:4 directed against N meningitidis serogroups A, C, W-135, and Y. [ Time Frame: 6-18 months post vaccination at 12 months of age ] [ Designated as safety issue: Yes ]

Enrollment:	662
Study Start Date:	March 2008
Study Completion Date:	October 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MenACWY(2dose)+Routine Vaccine 2 injections of Novartis Meningococcal ACWY (MenACWY) conjugate vaccine at 6-8 months and at 12 months of age,+ Concomitant injection of injection of PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa)at 12 months.	Biological: MenACWY 2 dose MenACWY (12 Month) + Concomitant Vaccination (12 Month)PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa). Biological: Routine Vaccines 1 dose MenACWY (12 Month) + Concomitant Vaccination (12 Month)PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa).
Experimental: MenACWY(1Dose)+Routine Vaccine 1 injection of Novartis Meningococcal ACWY (MenACWY)conjugate vaccine at 12 months of age + Concomitant injection of PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa) at 12 months.	Biological: MenACWY 2 dose MenACWY (12 Month) + Concomitant Vaccination (12 Month)PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa). Biological: Routine Vaccines 1 dose MenACWY (12 Month) + Concomitant Vaccination (12 Month)PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa).
Active Comparator: MenC(1 Dose)+Routine Vaccine 1 injection of Novartis Meningococcal C (MenC, Menjugate®) conjugate vaccine at 12 months of age + Concomitant injection of PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa) at 12 months.	Biological: Routine Vaccines 1 dose MenACWY (12 Month) + Concomitant Vaccination (12 Month)PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa). Biological: MenC 1 dose MenC (12 Month) + Concomitant Vaccination (12 Month) PCV7 (Prevenar®) and DTPa-IPV-HepB-Hib(Infanrix®-hexa).

Eligibility

Ages Eligible for Study:	6 Months to 8 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667602

Locations

Germany
Site 22
Bad Kreuznach, Germany, 55543
Site 38
Bad Lobenstein, Germany, 07356
Site 24
Balve, Germany, 58802
Site 31
Berlin, Germany, 13189
Site 3
Berlin, Germany, 12589
Site 27
Berlin, Germany, 12619
Site 26
Berlin, Germany, 12627
Site 25
Berlin, Germany, 13347
Site 20
Berlin, Germany, 12627
Site 13
Berlin, Germany, 13189
Site 15
Bönnigheim, Germany, 74357
Site 39
Eschwege, Germany, 37269
Site 32
Flensburg, Germany, 24937
Site 16
Frankenthal, Germany, 67227
Site 18
Fulda, Germany, 36037
Site 33
Glücksburg, Germany, 24960
Site 35
Hamburg, Germany, 22147
Site 2
Kehl, Germany, 77694
Site 28
Mainz, Germany, 55127
Site 44
Mainz, Germany, 55131
Site 43
München-Ramersdorf, Germany, 81669
Site 42
Neuhaus am Rennweg, Germany, 98724
Site 21
Neumünster, Germany, 24534
Site 9
Neumünster, Germany, 24534
Site 10
Oberstenfeld, Germany, 71720
Site 4
Stuttgart, Germany, 70193
Site 19
Stuttgart, Germany, 70469
Site 30
Weilheim i OB, Germany, 82362
Site 6
Wiesloch, Germany, 69168

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00667602 History of Changes
Other Study ID Numbers:	V59P22, 2007-004754-82
Study First Received:	April 24, 2008
Last Updated:	February 1, 2013
Health Authority:	United States: Food and Drug Administration Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

Meningococcal
ACWY
Conjugate Vaccine
Meningitis

Toddlers
Infants
Concomitant Vaccination

Additional relevant MeSH terms:

Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial

Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013