Phase 3
Completed N=1,588
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Meningococcal Disease · Meningococcal Meningitis
Source: ClinicalTrials.gov NCT00944034 ↗
Enrolled (actual)
1,588
Serious AEs
3.8%
Results posted
Nov 2015
Primary outcomePrimary: Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age. — 97; 100; 100; 100 percentage of subjects
Summary
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age. |
97; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age. |
100; 99; 100; 100; 100; 100 | — |
| SECONDARY Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age. |
100; 98; 100; 100; 100; 100 | — |
| SECONDARY Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age. |
125; 123; 108; 178; 164; 152 | — |
| SECONDARY GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age |
125; 179; 137; 18; 1301; 1763 | — |
| SECONDARY GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age |
126; 110; 162; 155; 93; 132 | — |
| SECONDARY Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months |
188; 171; 177; 635; 491; 559 | — |
| SECONDARY Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age. |
5334; 6395; 6864; 6605; 6418; 8120 | — |
| SECONDARY Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age. |
122; 121; 100 | — |
| SECONDARY Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age. |
156; 135; 116; 137; 119; 113 | — |
| SECONDARY Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age. |
151; 35; 47; 143; 32; 42 | — |
Eligibility Criteria
Inclusion Criteria
Follow-on participants of V72P12:
Healthy toddlers who completed Study V72P12, aged:
- 12 months or older - Groups 1a, 2a, 3a, 4
- 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
- 24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Naive subjects newly enrolled:
- Group 5: healthy 18-month-old toddlers (0/ +29 days window)
- Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Exclusion Criteria
- History of any meningococcal B vaccine administration (only for groups 5 and 6);
- Previous ascertained or suspected disease caused by N. meningitidis;
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
- Antibiotics within 6 days prior to enrollment;
- Any serious chronic or progressive disease;
- Known or suspected impairment or alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Data sourced from ClinicalTrials.gov (NCT00944034). 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. Informational only — not medical advice.