A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
- Conditions
- Meningococcal DiseaseMeningococcal Meningitis
- Interventions
- Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
- Registration Number
- NCT01018732
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
- Detailed Description
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
- Female subjects were to be negative for pregnancy
- History of meningococcal disease
- Receipt of any meningococcal vaccine outside of parent study (V59P6)
- Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
- receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
- any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I: MenACWY-CRM vaccine Novartis Meningococcal (MenACWY-CRM) vaccine Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study. II: Licensed Polysaccharide Meningococcal vaccine Novartis Meningococcal (MenACWY-CRM) vaccine Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study. III: Meningococcal Naive Novartis Meningococcal (MenACWY-CRM) vaccine Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.
- Primary Outcome Measures
Name Time Method Geometric Mean Titer After Booster Vaccination Day 8, Day 29 (5 years after primary vaccination) Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination Day 1 (5 years after primary vaccination) Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
- Secondary Outcome Measures
Name Time Method Geometric Mean Ratio After Booster Vaccination Day 8 and Day 29 (at 5 Years After Primary Vaccination) Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination Up to Day 7 Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination Day 1 (5 years after primary vaccination ) Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Geometric Mean Titer at 5 Years After Primary Vaccination Day 1 (5 years after primary vaccination ) Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination Day 7, Day 28 post booster (5 years after primary vaccination) Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination Day 8, Day 29 (5 years after primary vaccination) For a subject with hSBA titer \<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \>=8; and for a subject with hSBA titer \>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination Day 7, Day 28 post booster (5 years after primary vaccination) Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.