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Completed

NCT Number: NCT00262041

Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

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.

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Key information

Conditions

Prevention of Meningococcal Disease

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rochester, Minnesota, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

MenACWY-CRM conjugate vaccine, adjuvanted

Biological

MenACWY-CRM conjugate vaccine, unadjuvanted

Biological

MenACWY polysaccharide vaccine

Biological

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

    Time frame: 1 month after vaccination

    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

Secondary outcomes

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

    Time frame: 1 month after vaccination

    Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.

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

    Time frame: 12 months after vaccination

    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.

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

    Time frame: 12 months after vaccination

    Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.

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

    Time frame: Day 1 to Day 7

    Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Novartis

Registry information

Official study title

A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 6, 2005
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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