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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01717638
First received: October 18, 2012
Last updated: November 7, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.



Enrollment: 805
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: September 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
Criteria

Inclusion Criteria:

A. Inclusion Criteria for naïve subjects, newly enrolled (Group 7):

  1. 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.
  2. For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
  3. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
  4. 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):

  1. Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study.
  2. History of any meningococcal B vaccine administration.
  3. Previous ascertained or suspected disease caused by N. meningitidis.
  4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
  5. History of allergic reaction to any vaccine component.
  6. Significant chronic infection.
  7. 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).
  8. Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
  9. Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
  10. Family members and household members of research staff.
  11. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717638

Locations
Czech Republic
Ordinace praktickeho lekare pro deti a dorost
Jaromer, Alšova 466, Czech Republic, 55101
Ordinace praktickeho lekare pro deti a dorost
Jaromer, Dr. E.Beneše 191, Czech Republic, 55101
Ordinace praktickeho lekare pro deti a dorost
Sezemice, Havlickova 168, Czech Republic, 53304
Ordinace praktickeho lekare pro deti a dorost
Hronov, Hostovského 485, Czech Republic, 54931
Ordinace praktickeho lekare pro deti a dorost
Ceska Skalice, Husovo namesti 36, Czech Republic, 55203
Nemocnice Pardubice
Pardubice, Kyjevska 44, Czech Republic, 53203
Ordinace praktickeho lekare pro deti a dorost
Pardubice, L.Male 656, Czech Republic, 53012
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Manesova 646, Czech Republic, 50002
Biovomed
Hradec Kralove, Mikolase Alse 639/5, Czech Republic, 50002
Ordinace praktickeho lekare pro deti a dorost
Hronov, Palackeho 517, Czech Republic, 54931
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Pardubicka 752, Czech Republic, 50004
Ordinace praktickeho lekare pro deti a dorost
Chlumec nad Cidlinou, Pernstynska 127/I, Czech Republic, 50351
Nemocnice Náchod
Nachod, Purkynova 446, Czech Republic, 54701
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, Ruských legií 352, Czech Republic, 37701
Ordinace praktickeho lekare pro deti a dorost
Pardubice, Sladkovskeho 2617, Czech Republic, 53002
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, Sídliste Vajgar 724/III, Czech Republic, 37701
Fakulta vojenskeho zdravotnictvi UO
Hradec Kralove, Trebesska 1575, Czech Republic, 50001
Ordinace praktickeho lekare pro deti a dorost
Holice, U kaplicky 1042, Czech Republic, 53401
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, U nemocnice380/III, Czech Republic, 37701
Italy
Universita di Firenze -Pediatria
Florence, Italy, 50139
IRCCS Cà Granda
Milan, Italy, 20122
Ospedale Maggiore della Carita
Novara, Italy, 28100
Dip Pediatria AO Padova
Padova, Italy, 35128
Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela A Coruña, Spain, 15706
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
Valencia, Spain, 46020/46001
Complexo Hospitalario Xeral Cies
Vigo Pontevedra, Spain, 36204
United Kingdom
Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
Oxford, Headington, United Kingdom, OX3 7LJ
North Bristol NHS Trust
Bristol, United Kingdom, BS1 3NU
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
St Georges Hospital
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  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: November 7, 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 July 24, 2014