Back to resultsA Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Primary Purpose
Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis
Status
Completed
Phase
Phase 3
Locations
Costa Rica
Study Type
Interventional
Intervention
Novartis Meningococcal ACWY Conjugate Vaccine
Tdap Vaccine
Novartis Meningococcal ACWY Conjugate Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal, meningitis, vaccine, adolescents
Eligibility Criteria
Inclusion Criteria:
- Healthy adolescents 11-18 years of age
- virgins (both male and female) with no intention of becoming sexually active during the study period
- who have been properly vaccinated against diphtheria, tetanus, pertussis
Exclusion Criteria:
- who had a previous confirmed or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine
- who have received prior human papillomavirus (HPV) vaccine;
- who have any serious acute, chronic or progressive disease
- who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- who have Down's syndrome or other known cytogenic disorders;
Sites / Locations
- San Jose, Costa Rica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
MenACWY + Tdap + HPV
MenACWY →Tdap → HPV
Tdap →MenACWY → HPV
Arm Description
Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8
Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
Outcomes
Primary Outcome Measures
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Secondary Outcome Measures
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
Percentage of Subjects With Anti-HPV Seroconversion
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
Geometric Mean Titers (GMT) of Pertussis Antigens
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00518180
Brief Title
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Official Title
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
Keywords
Meningococcal, meningitis, vaccine, adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1620 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MenACWY + Tdap + HPV
Arm Type
Experimental
Arm Description
Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
Arm Title
MenACWY →Tdap → HPV
Arm Type
Experimental
Arm Description
Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8
Arm Title
Tdap →MenACWY → HPV
Arm Type
Experimental
Arm Description
Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
Intervention Type
Biological
Intervention Name(s)
Novartis Meningococcal ACWY Conjugate Vaccine
Intervention Description
One dose of vaccine administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Tdap Vaccine
Intervention Description
One dose of vaccine administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Novartis Meningococcal ACWY Conjugate Vaccine
Intervention Description
One dose of vaccine administered intramuscularly
Primary Outcome Measure Information:
Title
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Description
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month post MenACWY vaccination
Title
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Description
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Time Frame
1 month post Tdap vaccination
Title
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
Description
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Time Frame
1 month post Tdap vaccination
Secondary Outcome Measure Information:
Title
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Description
The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
Time Frame
1 month post MenACWY vaccination
Title
Percentage of Subjects With Anti-HPV Seroconversion
Description
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
Time Frame
1 month post third HPV vaccination
Title
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
Description
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
Time Frame
1 month post third HPV vaccination
Title
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Description
The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
Time Frame
1 month post MenACWY vaccination
Title
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
Description
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Time Frame
1 month post Tdap vaccination
Title
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
Description
To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
Time Frame
1 month post Tdap vaccination
Title
Geometric Mean Titers (GMT) of Pertussis Antigens
Description
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Time Frame
1 month post Tdap vaccination
Title
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Description
To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
Time Frame
1 month post Tdap vaccination
Title
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Description
Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
Time Frame
Days 1 to 7
Title
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Description
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Time Frame
Days 1 to 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adolescents 11-18 years of age
virgins (both male and female) with no intention of becoming sexually active during the study period
who have been properly vaccinated against diphtheria, tetanus, pertussis
Exclusion Criteria:
who had a previous confirmed or suspected disease caused by N. meningitidis;
who have previously been immunized with a meningococcal vaccine
who have received prior human papillomavirus (HPV) vaccine;
who have any serious acute, chronic or progressive disease
who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
who have a known or suspected impairment/alteration of immune function, either congenital or acquired
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
who have Down's syndrome or other known cytogenic disorders;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
San Jose, Costa Rica
City
San Jose
Country
Costa Rica
12. IPD Sharing Statement
Citations:
PubMed Identifier
20189491
Citation
Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.
Results Reference
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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
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