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
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Purpose
It is a Phase 3 extension of study V72P12E1. 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), 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease Meningococcal Meningitis |
Biological: MenB+OMV NZ Biological: MenB + OMV NZ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1 |
- Percentage of subjects with SBA persistence, hSBA ≥1:5 and hSBA ≥1:4 to N.meningitidis serogroups B [ Time Frame: Throughout individual subject participation -Groups 1 and 2 subset 1: 1 day; Groups 1 and 2 subset 2 and Groups 3, 4, 5, 6: 1 month ] [ Designated as safety issue: No ]To explore antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ administered to toddlers in study V72P12E1, who previously received a three-dose primary series of rMenB+OMV NZ as infants in the study V72P12.
- SBA geometric mean titers (GMT) and geometric mean ratios(GMR) based on GMTs at 1 month after last rMenB+OMV NZ booster dose in V72P12E1 study. [ Time Frame: Throughout individual subject participation-Groups 1 and 2 subset 1: 1 day; Groups 1 and 2 subset 2 and Groups 3, 4, 5, 6: 1 month ] [ Designated as safety issue: No ]
- Percentage of subjects with SBA persistence, hSB ≥1:5 and hSBA ≥1:4 to N. meningitidis serogroups B, SBA GMTs and GMRs based on GMTs at 1 month after last rMenB+OMV NZ booster dose in V72P12E1 study. [ Time Frame: Throughout individual subject participation - Groups 1 and 2 subset 2 and Groups 3, 4, 5, 6: 1 month; Group 7: 3 months ] [ Designated as safety issue: No ]
- SBA GMTs, percentage of subjects with hSBA ≥ 1:5 and ≥ 1:8, and fourfold increase to each of the four indicator strains. [ Time Frame: Throughout individual subject participation - Groups 1 and 2 subset 2 and Groups 3, 4, 5, 6: 1 month; Group 7: 3 months ] [ Designated as safety issue: No ]
- Local and systemic reactions and Adverse Events [ Time Frame: For 7 days after study vaccination with rMenB+OMV NZ ] [ Designated as safety issue: Yes ]
Local reactions: Pain, erythema, induration, swelling systemic Reactions: Fever [i.e., axillary temperature ≥ 38.0°C], change in eating habits, sleepiness, vomiting, diarrhea, irritability, headache, arthralgia and rash.
Local and systemic reactions and Adverse Events will be collected for 7 days after each vaccination. In addition, Serious Adverse Events, Medically Attended Adverse Events and Adverse Events leading to premature withdrawal will be collected throughout the course of the study.
| Estimated Enrollment: | 1700 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Subset 1
Non-vaccination subset of Groups 1 and 2
|
|
|
Experimental: MenB+OMV NZ-5th dose
Vaccination subset of Groups 1 and 2
|
Biological: MenB+OMV NZ
0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
|
| Experimental: Group 3: MenB+OMV NZ - 5th dose |
Biological: MenB+OMV NZ
0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
|
| Experimental: Group 4: MenB+OMV NZ-3rd dose |
Biological: MenB+OMV NZ
0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
|
| Experimental: Group 5: MenB+OMV NZ-3rd dose |
Biological: MenB+OMV NZ
0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
|
| Experimental: Group 6: MenB+OMV NZ-3rd dose |
Biological: MenB+OMV NZ
0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
|
| Experimental: Group 7: MenB+OMV NZ-2 catch-up |
Biological: MenB + OMV NZ
0.5 mL single dose of rMenB+OMV NZ, Intramuscular, 2 doses 2 months apart
|
Eligibility| Ages Eligible for Study: | 48 Months to 60 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A. Inclusion Criteria for naïve subjects, newly enrolled (Group 7):
- 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 1, 2, 3, 4, 5, and 6):
Inclusion criteria are the same as for Groups 7, 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 1, 2, 3, 4, 5, and 6):
Exclusion criteria are the same as for Group 7, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 9.
Contacts and Locations| Contact: Novartis Drug Information Services | +1 800 244 ext 7668 |
| Czech Republic | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Jaromer, Alšova 466, Czech Republic, 55101 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Jaromer, Dr. E.Beneše 191, Czech Republic, 55101 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Sezemice, Havlickova 168, Czech Republic, 53304 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Hronov, Hostovského 485, Czech Republic, 54931 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Ceska Skalice, Husovo namesti 36, Czech Republic, 55203 | |
| Nemocnice Pardubice | Recruiting |
| Pardubice, Kyjevska 44, Czech Republic, 53203 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Pardubice, L.Male 656, Czech Republic, 53012 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Hradec Králové, Manesova 646, Czech Republic, 50002 | |
| Biovomed | Recruiting |
| Hradec Kralove, Mikolase Alse 639/5, Czech Republic, 50002 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Hronov, Palackeho 517, Czech Republic, 54931 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Hradec Králové, Pardubicka 752, Czech Republic, 50004 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Chlumec nad Cidlinou, Pernstynska 127/I, Czech Republic, 50351 | |
| Nemocnice Náchod | Recruiting |
| Nachod, Purkynova 446, Czech Republic, 54701 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Jindrichuv Hradec, Ruských legií 352, Czech Republic, 37701 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Pardubice, Sladkovskeho 2617, Czech Republic, 53002 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Jindrichuv Hradec, Sídliste Vajgar 724/III, Czech Republic, 37701 | |
| Fakulta vojenskeho zdravotnictvi UO | Recruiting |
| Hradec Kralove, Trebesska 1575, Czech Republic, 50001 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Holice, U kaplicky 1042, Czech Republic, 53401 | |
| Ordinace praktickeho lekare pro deti a dorost | Recruiting |
| Jindrichuv Hradec, U nemocnice380/III, Czech Republic, 37701 | |
| Italy | |
| Universita di Firenze -Pediatria | Recruiting |
| Florence, Italy, 50139 | |
| IRCCS Cà Granda | Recruiting |
| Milan, Italy, 20122 | |
| Ospedale Maggiore della Carita | Recruiting |
| Novara, Italy, 28100 | |
| Dip Pediatria AO Padova | Recruiting |
| Padova, Italy, 35128 | |
| Spain | |
| Hospital Clinico Universitario de Santiago de Compostela | Recruiting |
| Santiago de Compostela A Coruña, Spain, 15706 | |
| Hospital Universitario Dr. Peset | Recruiting |
| Valencia, Spain, 46017 | |
| Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir | Recruiting |
| Valencia, Spain, 46020/46001 | |
| Complexo Hospitalario Xeral Cies | Recruiting |
| Vigo Pontevedra, Spain, 36204 | |
| United Kingdom | |
| Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital | Recruiting |
| Oxford, Headington, United Kingdom, OX3 7LJ | |
| North Bristol NHS Trust | Recruiting |
| Bristol, United Kingdom, BS1 3NU | |
| Royal Devon and Exeter NHS Foundation Trust | Recruiting |
| Exeter, United Kingdom, EX2 5DW | |
| St Georges Hospital | Recruiting |
| London, United Kingdom, SW17 0RE | |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01717638 History of Changes |
| Other Study ID Numbers: | V72P12E2, 2011-004931-30 |
| Study First Received: | October 18, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Novartis:
|
Meningococcal disease, vaccines, children, persistence |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Meningococcal Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
Meningitis, Bacterial Central Nervous System Bacterial Infections Bacterial Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013