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

NCT ID: NCT00667602

Last Updated: 2013-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

662 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Meningococcal Meningitis

Keywords

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Meningococcal ACWY Conjugate Vaccine Meningitis Toddlers Infants Concomitant Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MenACWY-CRM197 (2 doses) + Concomitant Vaccines

Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months.

Group Type EXPERIMENTAL

MenACWY-CRM197 (two doses)

Intervention Type BIOLOGICAL

Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

PCV7

Intervention Type BIOLOGICAL

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

DTPa-IPV-HepB-Hib

Intervention Type BIOLOGICAL

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

MenACWY-CRM197 (1 dose) + Concomitant Vaccines

Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.

Group Type EXPERIMENTAL

PCV7

Intervention Type BIOLOGICAL

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

DTPa-IPV-HepB-Hib

Intervention Type BIOLOGICAL

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

MenACWY-CRM197 (one dose)

Intervention Type BIOLOGICAL

One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

MenC (1 dose) + Concomitant Vaccines

Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.

Group Type ACTIVE_COMPARATOR

MenC

Intervention Type BIOLOGICAL

One 0.5mL dose of MenC vaccine was administered by intramuscular injection.

PCV7

Intervention Type BIOLOGICAL

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

DTPa-IPV-HepB-Hib

Intervention Type BIOLOGICAL

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

Interventions

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MenACWY-CRM197 (two doses)

Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Intervention Type BIOLOGICAL

MenC

One 0.5mL dose of MenC vaccine was administered by intramuscular injection.

Intervention Type BIOLOGICAL

PCV7

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

Intervention Type BIOLOGICAL

DTPa-IPV-HepB-Hib

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

Intervention Type BIOLOGICAL

MenACWY-CRM197 (one dose)

One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Site 22

Bad Kreuznach, , Germany

Site Status

Site 38

Bad Lobenstein, , Germany

Site Status

Site 24

Balve, , Germany

Site Status

Site 3

Berlin, , Germany

Site Status

Site 27

Berlin, , Germany

Site Status

Site 20

Berlin, , Germany

Site Status

Site 26

Berlin, , Germany

Site Status

Site 13

Berlin, , Germany

Site Status

Site 31

Berlin, , Germany

Site Status

Site 25

Berlin, , Germany

Site Status

Site 15

Bönnigheim, , Germany

Site Status

Site 39

Eschwege, , Germany

Site Status

Site 32

Flensburg, , Germany

Site Status

Site 16

Frankenthal, , Germany

Site Status

Site 33

Glücksburg, , Germany

Site Status

Site 35

Hamburg, , Germany

Site Status

Site 2

Kehl, , Germany

Site Status

Site 28

Mainz, , Germany

Site Status

Site 44

Mainz, , Germany

Site Status

Site 43

München-Ramersdorf, , Germany

Site Status

Site 42

Neuhaus am Rennweg, , Germany

Site Status

Site 21

Neumünster, , Germany

Site Status

Site 9

Neumünster, , Germany

Site Status

Site 10

Oberstenfeld, , Germany

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Site 4

Stuttgart, , Germany

Site Status

Site 19

Stuttgart, , Germany

Site Status

Site 30

Weilheim I OB, , Germany

Site Status

Site 6

Wiesloch, , Germany

Site Status

Countries

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Australia Germany

References

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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.

Reference Type DERIVED
PMID: 33325757 (View on PubMed)

Other Identifiers

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2007-004754-82

Identifier Type: -

Identifier Source: secondary_id

V59P22

Identifier Type: -

Identifier Source: org_study_id