Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
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ClinicalTrials.gov Identifier: NCT00262041 |
Recruitment Status
:
Completed
First Posted
: December 6, 2005
Results First Posted
: November 20, 2013
Last Update Posted
: October 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of Meningococcal Disease | Biological: MenACWY-CRM conjugate vaccine, adjuvanted Biological: MenACWY-CRM conjugate vaccine, unadjuvanted Biological: MenACWY polysaccharide vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 524 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Prevention |
Official 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 |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | March 2006 |
Study Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: MenACWY-CRM(Ad+)
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
Biological: MenACWY-CRM conjugate vaccine, adjuvanted |
Experimental: MenACWY-CRM(Ad-)
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted |
Active Comparator: MenACWY- PS
Subjects received one single dose of the polysaccharide vaccine.
|
Biological: MenACWY polysaccharide vaccine |
- 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
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 11 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262041
United States, Minnesota | |
Rochester, Minnesota, United States, 55905 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Washington | |
Seattle, Washington, United States, 98101 |
Study Director: | Novartis Vaccines | Novartis |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Vaccines |
ClinicalTrials.gov Identifier: | NCT00262041 History of Changes |
Other Study ID Numbers: |
V59P6 BB-IND 11278 |
First Posted: | December 6, 2005 Key Record Dates |
Results First Posted: | November 20, 2013 |
Last Update Posted: | October 27, 2016 |
Last Verified: | September 2016 |
Additional relevant MeSH terms:
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Vaccines Immunologic Factors Physiological Effects of Drugs |