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

Phase 3

Completed

Conditions: Human Papillomavirus Infection
Meningococcal Meningitis
Tetanus
Pertussis

Interventions: Biological: Tdap Vaccine
Biological: Novartis Meningococcal ACWY Conjugate Vaccine

Registration Number: NCT00518180

Lead Sponsor: Novartis Vaccines

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1620

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tdap →MenACWY → HPV	Tdap Vaccine	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
MenACWY + Tdap + HPV	Novartis Meningococcal ACWY Conjugate Vaccine	Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
MenACWY →Tdap → HPV	Novartis Meningococcal ACWY Conjugate Vaccine	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

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse	1 month post MenACWY vaccination	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	1 month post Tdap vaccination	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)	1 month post Tdap vaccination	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

Name	Time	Method
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups	1 month post MenACWY vaccination	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	1 month post third HPV vaccination	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.
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus	1 month post Tdap vaccination	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	1 month post Tdap vaccination	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	1 month post Tdap vaccination	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	1 month post Tdap vaccination	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.
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups	1 month post MenACWY vaccination	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.
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay	1 month post third HPV vaccination	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.)
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.	Days 1 to 7	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	Days 1 to 7	Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.