Phase 3
N=1,630
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00626327 ↗Enrolled (actual)
1,630
Serious AEs
2.9%
Results posted
Mar 2013
Primary outcome: Primary: Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine — 98; 99; 98; 96 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM + MMRV (Biological); MMRV (Biological); MenACWY-CRM (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine |
98; 99; 98; 96; 95; 97 | — |
| PRIMARY Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine. |
88; 88; 100; 100; 100; 98 | — |
| PRIMARY Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine |
88; 100; 98; 96 | — |
| SECONDARY Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine |
90; 91; 100; 100; 100; 99 | — |
| SECONDARY Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine |
39; 37; 194; 180; 132; 119 | — |
| SECONDARY Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine. |
74; 74; 4049; 3632; 5; 5 | — |
| SECONDARY Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine. |
99; 99 | — |
| SECONDARY Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine |
63; 50; 93; 88; 48; 37 | — |
| SECONDARY Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine |
8.16; 26; 5.11; 4.09 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination |
278; 298; 316; 133; 129; 0 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events After Vaccination |
335; 311; 353; 70; 2; 63 | — |
Summary
Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
Eligibility Criteria
Inclusion Criteria
- who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
- who have received complete primary vaccination with recommended licensed vaccines;
- who are available for all visits and telephone calls scheduled for the study;
Exclusion Criteria
- whose parent or legal guardian is unwilling or unable to give written informed assent consent
- who had a previous or suspected disease caused by N. meningitidis;
- who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
- who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
- who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination;
- who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
- who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome
- who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine,
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- who have Down's syndrome or other known cytogenic disorders; bleeding diathesis
Data sourced from ClinicalTrials.gov (NCT00626327). 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.