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Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT01994629
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE November 11, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE August 5, 2015
Results First Posted Date  ICMJE November 4, 2015
Last Update Posted Date November 4, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT. [ Time Frame: Day 1 to Day 7 post-vaccination ]
Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Percentage of subjects with at least one severe solicited Adverse Event reported [ Time Frame: between 6 hours and day 7 post vaccination ]
To assess the reactogenicity of MenACWY-CRM and MenACWY-TT vaccines, given to healthy toddlers at 12-15 months of age, as measured by the percentage of subjects with at least one severe solicited AE reported between 6 hours and Day 7 post vaccination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1, Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.
  • Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.
  • hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1, Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.
  • Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1, Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.
  • Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1, Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.
  • Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.
  • rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1, Day 29 and Day 180 post-vaccination ]
    Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.
  • Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1 (6 hours) to Day 7 post-vaccination ]
    Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
  • Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. [ Time Frame: Day 1 to Day 29 or Day 1 to Day 180 post-vaccination ]
    Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • hSBA titer ≥ 8 against serogroups A, C, W, Y [ Time Frame: day 29 and day 180 post vaccination ]
    To assess immune response to study vaccines on days 29 and 180, as measured by % subjects with hSBA titer ≥8, % subjects with hSBA seroresponse, and hSBA GMTs, and % subjects with rSBA titer ≥8 and ≥ 128, 4-fold rise, and rSBA GMTs, and to evaluate the reactogenicity and safety of the study vaccines
  • Percentage of subjects with hSBA seroresponse against serogroups A, C, W, Y [ Time Frame: day 29 and day 180 post vaccination ]
  • Adverse Events and other indicators of reactogenicity [ Time Frame: Day 1 to Day 180 post vaccination ]
  • hSBA GMTs against serogroups A, C, W, Y [ Time Frame: Day 29 and day 180 post vaccination ]
  • rSBA titer ≥ 8 against serogroups A, C, W, Y [ Time Frame: Day 29 and day 180 post vaccination ]
  • rSBA titer ≥ 128 against serogroups A, C, W, Y [ Time Frame: Day 29 and day 180 post vaccination ]
  • Four fold rise of rSBA titers against serogroups A, C, W, Y [ Time Frame: Day 29 and Day 180 post-vaccination ]
  • rSBA GMTs against serogroups A, C, W, Y [ Time Frame: Day 29 and day 180 post vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Official Title  ICMJE A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Brief Summary Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old healthy toddlers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Disease
Intervention  ICMJE
  • Biological: MenACWY-CRM
    MenACWY-CRM
  • Biological: MenACWY-TT
    MenACWY-TT
Study Arms  ICMJE
  • Experimental: MenACWY-CRM
    MenACWY-CRM
    Intervention: Biological: MenACWY-CRM
  • Active Comparator: MenACWY-TT
    MenACWY-TT
    Intervention: Biological: MenACWY-TT
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: April 17, 2014)
202
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
200
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks.
  2. Parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements.
  3. Parents/legal guardian available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls).
  4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  1. Previous confirmed or suspected disease caused by N. meningitidis.
  2. Previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease.
  3. Previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
  4. Received within 90 days prior to enrollment or were expected to receive during the study period any investigational or non-registered product (drug or vaccine).
  5. Received or planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exceptions: Injectable influenza vaccine could be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination).
  6. Major congenital defect or a serious chronic disease.
  7. History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.
  8. Required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids were allowed).
  9. Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period.
  10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  11. Any bleeding disorder which was considered as a contraindication to intramuscular injection.
  12. Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrollment.
  13. Systemic antibiotic treatment within 7 days prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994629
Other Study ID Numbers  ICMJE V59_67
2013-000862-13 ( EudraCT Number )
Has Data Monitoring Committee No
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 Not Provided
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date October 2015

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