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

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis; Human Papillomavirus Infection; Tetanus; Pertussis

Treatments: Biological: Novartis Meningococcal ACWY Conjugate Vaccine; Biological: Tdap Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518180

V59P18

Details and patient eligibility

About

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

Enrollment: 1,620 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,620 participants in 3 patient groups

MenACWY + Tdap + HPV

Experimental group

Description:

Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6

Treatment:

Biological: Novartis Meningococcal ACWY Conjugate Vaccine

Biological: Novartis Meningococcal ACWY Conjugate Vaccine

MenACWY →Tdap → HPV

Experimental group

Description:

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

Treatment:

Biological: Novartis Meningococcal ACWY Conjugate Vaccine

Biological: Novartis Meningococcal ACWY Conjugate Vaccine

Tdap →MenACWY → HPV

Experimental group

Description:

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

Treatment:

Biological: Tdap Vaccine