Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to evaluate the immunogenicity and describe the safety of
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate
      vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the
      United States (US). This study also evaluated the immunogenicity and safety of MenACYW
      Conjugate vaccine when given alone compared to when given concomitantly with tetanus,
      diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine.

      Primary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine
           when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was
           given alone.

      Secondary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine,
           when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines,
           compared to those when it was given alone.

        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap
           vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared
           to those when Tdap vaccine was given with HPV vaccine only.

        -  To evaluate the antibody responses to the antigens present in HPV vaccine after the
           3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW
           Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine
           is given with Tdap vaccine only.

      Observational objective:

        -  To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the
           licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV
           vaccines.
    

Detailed description: 
      Healthy adolescents were randomized and received a single dose of their assigned vaccines.
      They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days
      post-vaccination. Safety information were collected post-vaccination and throughout the
      entire study.
    

Intervention name(s): Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant; Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine; Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 milliliter (mL), Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): MenACYW Conjugate vaccine; MENVEO®; Adacel® (Tdap); GARDASIL® (HPV); MenACYW Conjugate vaccine; Adacel® (Tdap); GARDASIL® (HPV)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; MENVEO vaccine; Adacel®; GARDASIL®