A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus

Intervention / Treatment
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* Biological: Novartis Meningococcal ACWY Conjugate Vaccine
* Biological: Tdap Vaccine
* Biological: Novartis Meningococcal ACWY Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACWY + Tdap + HPV<br>Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6 | Biological: Novartis Meningococcal ACWY Conjugate Vaccine<br>* One dose of vaccine administered intramuscularly<br>|
| Experimental: MenACWY →Tdap → HPV<br>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 | Biological: Novartis Meningococcal ACWY Conjugate Vaccine<br>* One dose of vaccine administered intramuscularly<br>|
| Experimental: Tdap →MenACWY → HPV<br>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 | Biological: Tdap Vaccine<br>* One dose of vaccine administered intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month post MenACWY vaccination | 
| 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 | 1 month post Tdap vaccination | 
| 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 | 1 month post Tdap vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month post MenACWY vaccination | 
| 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. | 1 month post third HPV vaccination | 
| 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.) | 1 month post third HPV 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. | 1 month post MenACWY vaccination | 
| 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. | 1 month post Tdap vaccination | 
| 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. | 1 month post Tdap vaccination | 
| 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. | 1 month post Tdap vaccination | 
| 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. | 1 month post Tdap vaccination | 
| 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. | Days 1 to 7 | 
| 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. | Days 1 to 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal, meningitis, vaccine, adolescents