Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

NCT00329849 | Completed Phase 3 Results

• 1 other identifier: V59P10
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief Summary

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Conditions

Meningococcal Disease

Keywords

Meningitis; children; vaccine; safety; efficacy

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

  Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

  1 month after vaccination (day 29)

• Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination

  Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.

  Day 1 to 7 postvaccination

Secondary Outcomes (5)

• Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

  Day 1 and 29

• The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

  Day 1 and 29

• Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS

  Day 181

• The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS

  Day 181

• Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS

  Day 1 to 7 postvaccination

Study Arms (2)

MenACWY-CRM

EXPERIMENTAL

Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)

Biological: Meningococcal ACWY-CRM conjugate vaccine

MenACWY-PS

ACTIVE COMPARATOR

Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS)

Biological: Meningococcal ACWY-PS polysaccharide vaccine

Interventions

Meningococcal ACWY-CRM conjugate vaccine BIOLOGICAL

MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.

MenACWY-CRM

Meningococcal ACWY-PS polysaccharide vaccine BIOLOGICAL

MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

MenACWY-PS

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
• Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
• Good health as determined by the clinical judgment of the investigator.

You may not qualify if:

• Individuals not eligible to be enrolled into the study were those:
• whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
• whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period;
• who had a previous or suspected disease caused by N meningitidis;
• who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
• who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
• who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
• who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
• who had received a live viral vaccine within 60 days prior to enrollment;
• who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment;
• who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
• who had epilepsy or any progressive neurological disease;
• who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
• who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose \>1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

FUNCEI, French 3085

Buenos Aires, Argentina

Location

Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464

Córdoba, Argentina

Location

Hospital de Pediatria "Sor Maria Ludovica", Calle 14 N1631,(1900)

La Plata, Argentina

Location

Related Publications (1)

• Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4.

  PMID: 19895922 RESULT

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines & Diagnostics

  Novartis Vaccines & Diagnostics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: October 9, 2018
• Results First Posted: November 5, 2013

Record last verified: 2018-09

Locations

AR (3)