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

October 18, 2012
November 7, 2013
November 2012
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01717638 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningococcal Disease
  • Meningococcal Meningitis
  • Biological: MenB+OMV NZ
    0.5 mL of rMenB+OMV NZ, Intramuscular, single dose
  • Biological: MenB + OMV NZ
    0.5 mL single dose of rMenB+OMV NZ, Intramuscular, 2 doses 2 months apart
  • 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
    Intervention: Biological: MenB+OMV NZ
  • Experimental: Group 3: MenB+OMV NZ - 5th dose
    Intervention: Biological: MenB+OMV NZ
  • Experimental: Group 4: MenB+OMV NZ-3rd dose
    Intervention: Biological: MenB+OMV NZ
  • Experimental: Group 5: MenB+OMV NZ-3rd dose
    Intervention: Biological: MenB+OMV NZ
  • Experimental: Group 6: MenB+OMV NZ-3rd dose
    Intervention: Biological: MenB+OMV NZ
  • Experimental: Group 7: MenB+OMV NZ-2 catch-up
    Intervention: Biological: MenB + OMV NZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
805
October 2013
September 2013   (final data collection date for primary outcome measure)

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.

Both
48 Months to 60 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Italy,   Spain,   United Kingdom
 
NCT01717638
V72P12E2, 2011-004931-30
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP