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

Novartis Vaccines1,620 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,620

Conditions

Meningococcal Meningitis Human Papillomavirus Infection Pertussis Tetanus

Interventions

Novartis Meningococcal ACWY Conjugate VaccineBIOLOGICAL

One dose of vaccine administered intramuscularly

Tdap VaccineBIOLOGICAL

One dose of vaccine administered intramuscularly

Novartis Meningococcal ACWY Conjugate VaccineBIOLOGICAL

One dose of vaccine administered intramuscularly

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

San Jose, Costa Rica

San José, Costa Rica

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 1 month post Tdap vaccination

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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