Phase 3
N=2,907
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00616421 ↗Enrolled (actual)
2,907
Serious AEs
0.6%
Results posted
Jun 2011
Primary outcome: Primary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age — 72; 77; 60; 56 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM (Biological); Licensed meningococcal ACWY vaccine (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age |
72; 77; 60; 56; 72; 58 | — |
| PRIMARY Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. |
77; 83; 63; 57; 57; 44 | — |
| SECONDARY Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. |
74; 80; 61; 57; 65; 51 | — |
| SECONDARY Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age |
75; 80; 72; 68; 90; 60 | — |
| SECONDARY Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. |
30; 29; 23; 17; 49; 26 | — |
| SECONDARY Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. |
72; 78; 77; 83; 68; 64 | — |
| SECONDARY Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. |
26; 25; 35; 35; 18; 13 | — |
| SECONDARY Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) |
91; 72; 98; 60; 89; 72 | — |
| SECONDARY Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) |
91; 72; 99; 68; 99; 90 | — |
| SECONDARY GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) |
64; 27; 144; 18; 132; 41 | — |
| SECONDARY Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. |
33; 35; 27; 18; 18; 18 | — |
| SECONDARY Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. |
39; 45; 28; 22; 17; 13 | — |
| SECONDARY Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. |
26; 24; 5; 5; 1; 1 | — |
Summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Eligibility Criteria
Inclusion Criteria
- healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion Criteria
- whose parent or legal guardian is unwilling or unable to give written informed consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to enrollment
- who have any serious acute, chronic or progressive disease
- who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
- who have a history of anaphylaxis, serious vaccine reactions
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
- 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
Data sourced from ClinicalTrials.gov (NCT00616421). 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.