NCT00262041

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed
Last Updated

June 28, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

December 2, 2005

Results QC Date

September 9, 2013

Last Update Submit

May 17, 2018

Conditions

Prevention of Meningococcal Disease

Outcome Measures

Primary Outcomes (1)

  • Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine

    Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y

    1 month after vaccination

Secondary Outcomes (4)

  • hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine

    1 month after vaccination

  • Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine

    12 months after vaccination

  • hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine

    12 months after vaccination

  • Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination

    Day 1 to Day 7

Study Arms (3)

MenACWY-CRM(Ad+)

EXPERIMENTAL

Subjects received one single dose of adjuvanted formulation of conjugate vaccine.

Biological: MenACWY-CRM conjugate vaccine, adjuvanted

MenACWY-CRM(Ad-)

EXPERIMENTAL

Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY- PS

ACTIVE COMPARATOR

Subjects received one single dose of the polysaccharide vaccine.

Biological: MenACWY polysaccharide vaccine

Interventions

MenACWY-CRM conjugate vaccine, adjuvantedBIOLOGICAL
MenACWY-CRM(Ad+)
MenACWY-CRM conjugate vaccine, unadjuvantedBIOLOGICAL
MenACWY-CRM(Ad-)
MenACWY polysaccharide vaccineBIOLOGICAL
MenACWY- PS

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Healthy adolescents between and including 11-17 years of age, who provide written informed consent

You may not qualify if:

  • Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J. 2009 Feb;28(2):86-91. doi: 10.1097/INF.0b013e31818a0237.

    PMID: 19116603BACKGROUND

  • Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.

    PMID: 23114372DERIVED

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines

    Novartis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 6, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

June 28, 2018

Results First Posted

November 20, 2013

Record last verified: 2018-05

Locations

US(3)