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Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

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ClinicalTrials.gov Identifier: NCT00937521
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : March 4, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE July 13, 2009
Results First Submitted Date February 13, 2015
Results First Posted Date March 4, 2015
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
  • Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination [ Time Frame: At baseline (pre-vaccination) and 30 days after the third vaccination. ]
    To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
  • Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination [ Time Frame: Day 1 to day 3 after first vaccination. ]
    To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • Immune response one month after third vaccination [ Time Frame: 1 month ]
  • Safety and reactogenicity within 3 days after first vaccination [ Time Frame: 1 month ]
Change History Complete list of historical versions of study NCT00937521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
  • Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) [ Time Frame: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age) ]
    ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:
    1. One month after third vaccination.
    2. One month after booster vaccination (Men B at 12 months of age).
  • Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) [ Time Frame: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days ]
    To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
  • Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) [ Time Frame: After the third and the booster vaccination. ]
    To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
  • Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) [ Time Frame: 12 months (pre-fourth vaccination) ]
    To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
  • Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) [ Time Frame: 1 month after fourth vaccination ]
    To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
  • Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) [ Time Frame: At 13 months ]
    To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
  • Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) [ Time Frame: 1 month after booster ]
    To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
  • Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination [ Time Frame: Day 1 through day 7 after second and third vaccination. ]
    To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
  • Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination [ Time Frame: Day 1 through day 7 after each vaccination. ]
    To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
  • Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination [ Time Frame: Day 1 through day 7 after each vaccination. ]
    To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
  • Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination [ Time Frame: Day 1 through day 7 after each vaccination. ]
    To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
  • Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. [ Time Frame: Overall study period. ]
    To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
  • Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group [ Time Frame: Day 1 through day 7 at 13 months age. ]
    To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • To compare the immune response of study vaccines at 1 month after third vaccination [ Time Frame: 1 month ]
  • To compare the immune response of study vaccines and routine vaccines given with or without prophylactic antipyretic treatment [ Time Frame: 3 months ]
  • Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination [ Time Frame: 3 months ]
  • Safety and reactogenicity of study vaccines co-administered with routine vaccines as compared to control group [ Time Frame: 3 months ]
  • Solicited local and systemic reactions [ Time Frame: 3 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Official Title  ICMJE A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
Brief Summary This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Meningitis
  • Meningococcal Infections
Intervention  ICMJE
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation I
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation II
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation III
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation IV
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation V
  • Biological: Meningococcal B vaccine
    Vaccine candidate formulation VI
  • Biological: Control
    Control
  • Biological: Meningococcal B vaccine with antipyretic
    Vaccine candidate formulation I with antipyretic
Study Arms
  • 1
    Vaccine candidate formulation I
    Intervention: Biological: Meningococcal B vaccine
  • 2
    Vaccine candidate formulation II
    Intervention: Biological: Meningococcal B vaccine
  • 3
    Vaccine candidate formulation III
    Intervention: Biological: Meningococcal B vaccine
  • 4
    Vaccine candidate formulation IV
    Intervention: Biological: Meningococcal B vaccine
  • 5
    Vaccine candidate formulation V
    Intervention: Biological: Meningococcal B vaccine
  • 6
    Vaccine candidate formulation VI
    Intervention: Biological: Meningococcal B vaccine
  • 7
    Control
    Intervention: Biological: Control
  • 8
    Vaccine candidate formulation I with antipyretic
    Intervention: Biological: Meningococcal B vaccine with antipyretic
Publications * Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14. doi: 10.4161/hv.29218.

*   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: March 17, 2015)
1507
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2009)
1600
Actual Study Completion Date February 2012
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
  • Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Exclusion Criteria:

  • Any meningococcal B or C vaccine administration
  • Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
  • Any 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 severe allergic reaction after previous vaccinations
  • Recent significant acute or chronic infection
  • Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
  • 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)
  • Any impairment/alteration of the immune system resulting from (for example):

    • Receipt of any immunosuppressive therapy at any time since birth
    • Receipt of immunostimulants at any time since birth
    • Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
  • Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
  • Participation in another clinical trial
  • Family members and household members of research staff
  • History of seizure
  • Any contraindication to paracetamol
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Days to 89 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Czech Republic,   Hungary,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00937521
Other Study ID Numbers  ICMJE V72P16
2009-010106-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date March 2015

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