Clinical Trial Results:
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
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
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Summary
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EudraCT number |
2013-000862-13 |
Trial protocol |
IT |
Global end of trial date |
11 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Feb 2016
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First version publication date |
18 Feb 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V59_67
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01994629 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Sample data: Sample data | ||
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Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics
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Sponsor organisation address |
Via Fiorentina, 1, Siena, Italy, 53100
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Public contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Jul 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Oct 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the reactogenicity of MenACWY-cross reactive material (CRM) and MenACWY-tetanus toxoid (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 Adverse Event (AE) reported between 6 hours and Day 7 post vaccination.
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Protection of trial subjects |
This clinical study was designed and was to be implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practices (GCPs), with applicable local regulations including European Directive 2001/20/EC, United States (US) Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare, Novartis codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Nov 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 202
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Worldwide total number of subjects |
202
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EEA total number of subjects |
202
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
202
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled from 4 centers in Italy. | ||||||||||||||||||
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Pre-assignment
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Screening details |
All enrolled subjects were included in the trial. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MenACWY-CRM (12 to 15 months old) | ||||||||||||||||||
Arm description |
Subjects received one dose of investigational MenACWY-CRM vaccine. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine (ACWY-CRM, Menveo)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One 0.5 mL injection of MenACWY was administered IM in the anterolateral area of the right thigh.
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Arm title
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MenACWY-TT (12 to 15 months old) | ||||||||||||||||||
Arm description |
Subjects received one dose of comparator MenACWY-TT vaccine. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Meningococcal group A, C, W-135 and Y conjugate vaccine (ACWY-TT, Nimenrix)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One 0.5 mL injection of MenACWY was administered IM in the anterolateral area of the right thigh.
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Baseline characteristics reporting groups
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Reporting group title |
MenACWY-CRM (12 to 15 months old)
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Reporting group description |
Subjects received one dose of investigational MenACWY-CRM vaccine. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY-TT (12 to 15 months old)
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Reporting group description |
Subjects received one dose of comparator MenACWY-TT vaccine. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MenACWY-CRM (12 to 15 months old)
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Reporting group description |
Subjects received one dose of investigational MenACWY-CRM vaccine. | ||
Reporting group title |
MenACWY-TT (12 to 15 months old)
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Reporting group description |
Subjects received one dose of comparator MenACWY-TT vaccine. | ||
Subject analysis set title |
All enrolled set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects who provide informed consent and received a Subject Number.
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Subject analysis set title |
All Exposed Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects in the Enrolled Set who receive a study vaccination.
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Subject analysis set title |
FAS Immunogenicity, Day 180
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects in the enrolled set who: received the study vaccine and provided immunogenicity data at visit Day 180.
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Subject analysis set title |
Per Protocol Set (PPS), Immunogenicity, Day 29
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the FAS Immunogenicity who:
- were not excluded due to reasons defined prior to unblinding or
- analysis had no major protocol deviations.
Exclusions were considered by objective/time point (Visit Day 29 and visit Day 180).
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Subject analysis set title |
Full Analysis Set (FAS) Immunogenicity, Day 29
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects in the enrolled set who received the study vaccine and provided immunogenicity data at visit Day 29.
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Subject analysis set title |
PPS, Immunogenicity, Day 180
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All subjects in the FAS Immunogenicity who:
- were not excluded due to reasons defined prior to unblinding or
- analysis had no major protocol deviations.
Exclusions were considered by objective/time point (Visit Day 29 and visit Day 180).
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End point title |
1. Number of subjects reporting at least one severe solicited adverse event (AE) after receiving one dose of either MenACWY-CRM vaccine or MenACWY-TT vaccine. [1] | ||||||||||||
End point description |
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. Analysis was done on solicited safety data set ie, all subjects in the exposed set who provided post-vaccination reactogenicity data.
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End point type |
Primary
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End point timeframe |
Day 1 to Day 7 post-vaccination.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: statistical analyses not applicable. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
2. 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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. Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 1, Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
3. Percentages of subjects with seroresponse against N. meningitidis against serogroups A, C, W, and Y after receiving one dose of either MenACWY-CRM vaccine or MenACWY-TT vaccine. | ||||||||||||||||||||||||||||||||||||
End point description |
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 percentages of subjects with seroresponse at Day 180 after vaccination. Analysis was done on FAS at Visit Day 29 ie, all subjects who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
4. 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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. Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 1, Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
5. 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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 rSBA titer ≥ 8 on Day 180 after vaccination. Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 1, Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
6. 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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 responses was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180. Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 1, Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
7. 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. | ||||||||||||||||||||||||||||||||||||
End point description |
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 responses was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination. Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
8. 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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.Analysis was done on FAS at Visit Day 29 ie, all subjects in the enrolled set who received the study vaccine and provided immunogenicity data at Visit Day 29 (MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180, ie, all subjects in the enrolled set who received the study vaccine and provide immunogenicity data at Visit Day 180 (Men ACWY-CRM 98; MenACWT-TT 97).
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End point type |
Secondary
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End point timeframe |
Day 1, Day 29 and Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
9. Number of subjects reporting solicited adverse events (AEs) after receiving one dose of either MenACWY-CRM vaccine or MenACWY-TT vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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. Analysis was done on solicited safety data set.
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End point type |
Secondary
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End point timeframe |
Day 1 (6 hours) to Day 7 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
10. Number of subjects reporting unsolicited adverse events (AEs) after receiving one dose of either MenACWY-CRM vaccine or MenACWY-TT vaccine. | ||||||||||||||||||||||||
End point description |
Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (Day 1 to Day 29), Serious Adverse Events (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. Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 29 or Day 1 to Day 180 post-vaccination.
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Solicited AEs were collected from Day 1 to Day 7 post vaccination, unsolicited AEs were collected from Day 1 to Day 29 post vaccination and SAEs, medically attended AEs and AEs leading to premature withdrawal were collected from Day 1 to Day 180.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
MenACWY-TT (12 to 15 months old)
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Reporting group description |
Subjects received one dose of comparator MenACWY-TT vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY-CRM (12 to 15 months old)
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Reporting group description |
Subjects received one dose of investigational MenACWY-CRM vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Feb 2014 |
The end of study was defined in compliance with a newly implemented Novartis policy.
Duration of collection of concomitant medications was changed to 28 days after vaccination only, instead of collection over the entire study duration.
Minor inconsistencies and typographical errors have been corrected. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
