Phase 3
Completed N=805
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
Meningococcal Disease · Meningococcal Meningitis
Source: ClinicalTrials.gov NCT01717638 ↗
Enrolled (actual)
805
Serious AEs
0.5%
Results posted
Jan 2015
Primary outcomePrimary: Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules — 12; 18; 24; 20 Percentages of subjects
Summary
It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1.
In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1.
Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules |
12; 18; 24; 20; 27; 35 | — |
| PRIMARY Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules |
1.75; 1.68; 2.41; 1.72; 1.99; 2.69 | — |
| PRIMARY Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules |
0.012; 0.013; 0.023; 0.0092; 0.013; 0.023 | — |
| SECONDARY Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules |
11; 9; 9; 0; 84; 100 | — |
| SECONDARY Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules |
1.61; 2.03; 1.69; 1.04; 23; 47 | — |
| SECONDARY GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules |
0.092; 0.18; 0.2; 0.45; 1.9; 1.36 | — |
| SECONDARY Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules |
108; 115; 107; 173; 191; 212 | — |
| SECONDARY Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules |
60; 72; 41; 77; 88; 46 | — |
| SECONDARY Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules |
92; 100; 100; 100; 96; 93 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules |
100; 100; 100; 71; 100; 100 | — |
| SECONDARY GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules |
154; 145; 211; 11; 1575; 2381 | — |
| SECONDARY GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules. |
99; 67; 133; 10; 70; 51 | — |
| SECONDARY Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine |
99; 90; 100; 63; 100; 90 | — |
| SECONDARY Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age. |
100; 100; 91; 100; 100; 80 | — |
| SECONDARY GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age |
109; 343; 17; 47 | — |
| SECONDARY GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age |
105; 299; 17; 5.12 | — |
| SECONDARY Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age |
100; 99; 80; 51 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) |
27; 18; 17; 16; 24; 17 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) |
94; 9; 11; 33; 2; 2 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age |
186; 161; 81; 70; 77; 66 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) |
8; 4; 4; 7; 7; 3 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) |
25; 2; 4; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs After Any Vaccination. |
105; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
A. Inclusion Criteria for naïve subjects, newly enrolled (B48\_50):
- 4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old.
- For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
- For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
- In good health as determined by medical history, physical examination, clinical judgment of the investigator.
B. Inclusion Criteria for follow-on participants (Groups B+R246 12\_48, B+R246 18\_48, B+R246 24\_48, B246 12\_48, B246 18\_48, B246 24\_48, B+R234 12\_48, B+R234 18\_48, B+R234 24\_48, B12 14\_48, B18 20\_48, B24 26\_48):
Inclusion criteria are the same as for Group B48\_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.
Exclusion Criteria
A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7):
- Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study.
- History of any meningococcal B vaccine administration.
- Previous ascertained or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
- History of allergic reaction to any vaccine component.
- Significant chronic infection.
- Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
- Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
- Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
- Family members and household members of research staff.
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
B. Exclusion Criteria for follow-on participants ((Groups B+R246 12\_48, B+R246 18\_48, B+R246 24\_48, B246 12\_48, B246 18\_48, B246 24\_48, B+R234 12\_48, B+R234 18\_48, B+R234 24\_48, B12 14\_48, B18 20\_48, B24 26\_48):
Exclusion criteria are the same as for Group B48\_50, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 9.
Data sourced from ClinicalTrials.gov (NCT01717638). 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.