Phase 2
N=1,010
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Prevention of Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00262028 ↗Enrolled (actual)
1,010
Serious AEs
1.4%
Results posted
Feb 2016
Primary outcome: Primary: Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine — 6; 1; 228; 125 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MenACWY-CRM Vaccine (Biological); MenACWY-PS Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine |
6; 1; 228; 125; 80; 81 | — |
| SECONDARY Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine |
2; 0; 3; 1; 80; 43 | — |
| SECONDARY Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine |
0; 0; 81; 51; 3; 12 | — |
| SECONDARY hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
2.06; 2.02; 36; 6.31; 3.07; 3.33 | — |
| SECONDARY hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
2.04; 2; 2.08; 2.03; 28; 5.8 | — |
| SECONDARY hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine |
2; 2; 18; 7.18; 2.13; 2.44 | — |
| SECONDARY Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
6; 1; 2; 0; 4; 1 | — |
| SECONDARY hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
2.06; 2.02; 2.04; 2; 2.09; 2.04 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years |
56; 37; 70; 50; 43; 30 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months |
37; 29; 40; 35; 15; 17 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years |
56; 43; 45; 33; 6; 7 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months |
35; 33; 25; 30; 6; 1 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
Eligibility Criteria
Inclusion Criteria
- Group 1: Healthy children 2-10 years of age;
- Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.
Exclusion Criteria
- Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
- Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Data sourced from ClinicalTrials.gov (NCT00262028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.