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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518180
• Other study ID #: V59P18
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2007
• Last updated: February 4, 2016
• Start date: July 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCosta Rica: Ministry of Health Costa Rica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1620
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Meningitis
• Meningitis, Meningococcal
• Meningococcal Meningitis
• Papillomavirus Infections
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Novartis Meningococcal ACWY Conjugate Vaccine
One dose of vaccine administered intramuscularly
• Tdap Vaccine
One dose of vaccine administered intramuscularly
• Novartis Meningococcal ACWY Conjugate Vaccine
One dose of vaccine administered intramuscularly

Locations

Country	Name	City	State
Costa Rica	San Jose, Costa Rica	San Jose

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Costa Rica, 

References & Publications (1)

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 glycoc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes