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Trial record 2 of 3 for:    v72p12

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

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ClinicalTrials.gov Identifier: NCT00944034
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : November 10, 2015
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE July 21, 2009
First Posted Date  ICMJE July 22, 2009
Results First Submitted Date  ICMJE February 16, 2015
Results First Posted Date  ICMJE November 10, 2015
Last Update Posted Date August 14, 2017
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
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. [ Time Frame: 1 month after booster ]
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • Immunogenicity (SBA titer ), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ and routine concomitant vaccines at 2, 4 and 6 months of age) [ Time Frame: 1 month after booster ]
  • Safety and tolerability (body temperature, medically attended fever, use of antypiretics, AEs, solicited local and systemic reactions) of booster dose of rMenB+OMV NZ administered at 12 or 18 or 24 months of age [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • 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. [ Time Frame: 1 month after booster ]
    Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), 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.
  • 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. [ Time Frame: 1 month after booster ]
    Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.
  • 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. [ Time Frame: 1 month after booster ]
    The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
  • 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 [ Time Frame: 1 month after booster ]
    Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were 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 ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
  • 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 [ Time Frame: 1 month after booster ]
    Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were 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 ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
  • Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months [ Time Frame: 1 month after second vaccination ]
    Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
  • 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. [ Time Frame: 1 month after booster vaccination ]
    Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.
  • 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. [ Time Frame: 1 month after booster vaccination ]
    Immunogenicity evaluation 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.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA
  • 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. [ Time Frame: From day 1 to day 7 after vaccination ]
    The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
  • 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. [ Time Frame: day 1 to day 7 after vaccination ]
    The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • Immunogenicity (SBA titer, SBA GMTs), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age without concomitant routine vaccines) [ Time Frame: 1 month after booster ]
  • Immunogenicity (SBA titer, SBA GMTs), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ and concomitant routine vaccines at 2, 3, 4 months of age) [ Time Frame: 1 month after booster ]
  • Bactericidal antibody persistence (SBA GMTs, SBA titer) in 12-, 18- and 24-month-old toddlers previously primed (primary immunization with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age) and in naïve toddlers as control [ Time Frame: 1 months after booster ]
  • Immunological memory (SBA GMT) 1 month after booster vaccination at 12 or 18 or 24 months of age AND after a single dose given to naïve subjects at 12 or 18 or 24 months of age [ Time Frame: 1 months after booster ]
  • Immunogenicity (SBA titer), safety and tolerability (body temperature, medically attended fever, use of antipyretics, AEs, solicited local and systemic reactions) of a two-dose catch-up regimen in unprimed toddlers aged 12, 18 or 24 months. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Disease
  • Meningococcal Meningitis
Intervention  ICMJE
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
  • Biological: rMenB+OMV NZ
    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
  • Biological: rMenB+OMV NZ
    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age
  • Biological: two doses of rMenB+OMV NZ
    two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
  • Biological: two doses of rMenB+OMV NZ
    two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age
  • Biological: rMenB+OMV NZ
    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
  • Biological: two doses of rMenB+OMV NZ
    two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age
  • Biological: rMenB+OMV NZ with routine vaccinations
    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age
Study Arms  ICMJE
  • Experimental: B+R246_12
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B+R246_18
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B+R246_24
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B246_12
    Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
    Intervention: Biological: rMenB+OMV NZ
  • Experimental: B246_18
    Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
    Intervention: Biological: rMenB+OMV NZ
  • Experimental: B246_24
    Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
    Intervention: Biological: rMenB+OMV NZ
  • Experimental: B+R234_12
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B+R234_18
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B+R234_24
    Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
    Intervention: Biological: rMenB+OMV NZ with routine vaccinations
  • Experimental: B12 14
    Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
    Intervention: Biological: two doses of rMenB+OMV NZ
  • Experimental: B18 20
    Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
    Intervention: Biological: two doses of rMenB+OMV NZ
  • Experimental: B24 26
    Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
    Intervention: Biological: two doses of rMenB+OMV NZ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2015)
1588
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2009)
1900
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00944034
Other Study ID Numbers  ICMJE V72P12E1
2009-011676-30
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2017

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