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

NCT00518180 | Completed Phase 3 Results

• 1 other identifier: V59P18
• Study Type: interventional
• Target: 1,620
• Locations: 1 country
• Sites: 1

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

Conditions

Meningococcal Meningitis; Human Papillomavirus Infection; Pertussis; Tetanus

Keywords

Meningococcal; meningitis; vaccine; adolescents

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups

  1 month post MenACWY vaccination

• Percentage of Subjects With Anti-HPV Seroconversion

  1 month post third HPV vaccination

• Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay

  1 month post third HPV vaccination

• Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups

  1 month post MenACWY vaccination

• The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus

  1 month post Tdap vaccination

Study Arms (3)

MenACWY + Tdap + HPV

EXPERIMENTAL

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

MenACWY →Tdap → HPV

EXPERIMENTAL

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

Tdap →MenACWY → HPV

EXPERIMENTAL

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

Interventions

Novartis Meningococcal ACWY Conjugate Vaccine BIOLOGICAL

One dose of vaccine administered intramuscularly

MenACWY + Tdap + HPV

Tdap Vaccine BIOLOGICAL

One dose of vaccine administered intramuscularly

Tdap →MenACWY → HPV

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

San Jose, Costa Rica

San José, Costa Rica

Location

Related 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 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.

  PMID: 20189491 RESULT

MeSH Terms

Conditions

Meningitis, Meningococcal; Papillomavirus Infections; Whooping Cough; Tetanus; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccine and Diagnostics

RegistryContactVaccinesUS@Novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 20, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 18, 2016
• Results First Posted: October 4, 2010

Record last verified: 2016-04

Locations

CO (1)