Phase 2
N=120
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01026974 ↗Enrolled (actual)
120
Serious AEs
5.9%
Results posted
Mar 2014
Primary outcome: Primary: Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. — 1.26; 2.55; 1.08; 41 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rMenB (Biological); rMenB+OMV NZ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. |
1.26; 2.55; 1.08; 41; 29; 1 | — |
| PRIMARY Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. |
14; 36; 3; 93; 100; 0 | — |
| PRIMARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. |
14; 14; 38; 10; 12; 34 | — |
| SECONDARY Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age |
100; 114; 8.89; 1007; 926; 27 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age |
100; 100; 72; 100; 100; 87 | — |
| SECONDARY Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age |
100; 93; 54; 100; 100; 76 | — |
| SECONDARY Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine |
9.37; 4.69; 1.09; 334; 119; 1.17 | — |
| SECONDARY Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine |
67; 67; 4; 100; 100; 4 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age |
100; 100; 100; 100; 90; 89 | — |
| SECONDARY Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. |
74; 83; 247; 331; 16; 14 | — |
| SECONDARY Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age |
100; 100; 100; 100; 73; 69 | — |
| SECONDARY Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. |
2.73; 24; 1; 14 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. |
38; 100; 0; 83 | — |
| SECONDARY Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. |
86; 103; 27 | — |
| SECONDARY Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. |
5187; 3662; 83 | — |
| SECONDARY Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine |
772; 358; 25 | — |
| SECONDARY Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age. |
612; 2164 | — |
| SECONDARY Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. |
87 | — |
| SECONDARY Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age |
100; 100; 21 | — |
| SECONDARY Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age |
77; 97 | — |
| SECONDARY Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age |
39; 48; 38; 46; 38; 46 | — |
Summary
The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if they have not already received these vaccines prior to enrollment.
Eligibility Criteria
Inclusion Criteria
- Healthy 40 to 44-months-old children, who participated and completed the study V72P9 (follow-on subjects)
- Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)
Exclusion Criteria
- Previous ascertained or suspected disease caused by N meningitidis
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
- Any serious chronic or progressive disease
- Known or suspected impairment/ alteration of the immune system
- Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Data sourced from ClinicalTrials.gov (NCT01026974). 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.