Clinical Trial: Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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' M
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 Summary:
Sponsor: Novartis Vaccines
Current Primary Outcome: 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 ]
Original Primary Outcome: Percentage of subjects with at least one severe solicited Adverse Event reported [ Time Frame: between 6 hours and day 7 post vaccination ]
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- 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 ]
Information By: Novartis
Dates:
Date Received: November 11, 2013
Date Started: November 2013
Date Completion:
Last Updated: October 2, 2015
Last Verified: October 2015
- hSBA titer ≥ 8 against serogroups A, C, W, Y [ Time Frame: day 29 and day 180 post vaccination ]