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Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02640404
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Intervention Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Enrollment 224
Recruitment Details Participants were enrolled from 06 June 2016 through 16 June 2016 at a single center in Vietnam.
Pre-assignment Details A total of 224 participants (112 for each group) were enrolled and vaccinated in the study.
Arm/Group Title Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years)
Hide Arm/Group Description Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1). Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Period Title: Overall Study
Started 112 112
Completed 110 112
Not Completed 2 0
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             1             0
Arm/Group Title Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years) Total
Hide Arm/Group Description Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1). Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 112 112 224
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 112 participants 112 participants 224 participants
9 to 23 months
112
 100.0%
0
   0.0%
112
  50.0%
2 to 11 years
0
   0.0%
43
  38.4%
43
  19.2%
12 to 17 years
0
   0.0%
33
  29.5%
33
  14.7%
18 to 55 years
0
   0.0%
36
  32.1%
36
  16.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
Female
52
  46.4%
57
  50.9%
109
  48.7%
Male
60
  53.6%
55
  49.1%
115
  51.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Vietnam Number Analyzed 112 participants 112 participants 224 participants
112 112 224
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Hide Description Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: >0 to <25 mm, Grade 2: >=25 to <50 mm, Grade 3: >=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
Time Frame Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Arm/Group Title Menactra® Vaccine (9 to 23 Months)
Hide Arm/Group Description:
Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Inj. site pain (post-vaccination 1) Number Analyzed 112 participants
15
  13.4%
Grade 3 Inj site pain (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Inj site pain (post-vaccination 2) Number Analyzed 110 participants
15
  13.6%
Grade 3 Inj site pain (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
Any Erythema (post-vaccination 1) Number Analyzed 112 participants
1
   0.9%
Grade 3 Erythema (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Erythema (post-vaccination 2) Number Analyzed 110 participants
2
   1.8%
Grade 3 Erythema (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
Any Swelling (post-vaccination 1) Number Analyzed 112 participants
1
   0.9%
Grade 3 Swelling (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Swelling (post-vaccination 2) Number Analyzed 110 participants
2
   1.8%
Grade 3 Swelling (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
2.Primary Outcome
Title Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
Hide Description Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated [children], no interference with activity [adolescents and adults]; Grade 2: sufficiently discomforting [children], some interference[adolescents and adults]; Grade 3: unable to perform usual activities[children]; significant interference with daily activities [adolescents and adults]), Erythema and Swelling (Grade 1: >0 to<25 mm [children], >=25 to <=50 mm [adolescents and adults]; Grade 2: >=25 to <50 mm [children], >=51 to <=100 mm [adolescents and adults], Grade 3: >=50 mm [children]; >100 mm[adolescents and adults]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Arm/Group Title Menactra® Vaccine (2 to 55 Years)
Hide Arm/Group Description:
Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Inj site pain
28
  25.0%
Grade 3 Inj site pain
1
   0.9%
Any Erythema
2
   1.8%
Grade 3 Erythema
0
   0.0%
Any Swelling
1
   0.9%
Grade 3 Swelling
0
   0.0%
3.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Hide Description Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.5 degree Celsius; Grade 2: >38.5 degree Celsius to <=39.5 degree Celsius; Grade 3: >39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: >=6 episodes per 24 hours), Crying abnormal (Grade 1: <1 hour; Grade 2: 1-3 hours; Grade 3: >3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses >=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
Time Frame Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Arm/Group Title Menactra® Vaccine (9 to 23 Months)
Hide Arm/Group Description:
Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fever (post-vaccination 1) Number Analyzed 112 participants
9
   8.0%
Grade 3 Fever (post-vaccination 1) Number Analyzed 112 participants
1
   0.9%
Any Fever (post-vaccination 2) Number Analyzed 110 participants
9
   8.2%
Grade 3 Fever (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
Any Vomiting (post-vaccination 1) Number Analyzed 112 participants
8
   7.1%
Grade 3 Vomiting (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Vomiting (post-vaccination 2) Number Analyzed 110 participants
10
   9.1%
Grade 3 Vomiting (post-vaccination 2) Number Analyzed 110 participants
1
   0.9%
Any Crying Abnormal (post-vaccination 1) Number Analyzed 112 participants
9
   8.0%
Grade 3 Crying Abnormal (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Crying Abnormal (post-vaccination 2) Number Analyzed 110 participants
8
   7.3%
Grade 3 Crying Abnormal (post-vaccination 2) Number Analyzed 110 participants
1
   0.9%
Any Drowsiness (post-vaccination 1) Number Analyzed 112 participants
6
   5.4%
Grade 3 Drowsiness (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Drowsiness (post-vaccination 2) Number Analyzed 110 participants
5
   4.5%
Grade 3 Drowsiness (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
Any Appetite lost (post-vaccination 1) Number Analyzed 112 participants
22
  19.6%
Grade 3 Appetite lost (post-vaccination 1) Number Analyzed 112 participants
0
   0.0%
Any Appetite lost (post-vaccination 2) Number Analyzed 110 participants
17
  15.5%
Grade 3 Appetite lost (post-vaccination 2) Number Analyzed 110 participants
0
   0.0%
Any Irritability (post-vaccination 1) Number Analyzed 112 participants
13
  11.6%
Grade 3 Irritability (post-vaccination 1) Number Analyzed 112 participants
1
   0.9%
Any Irritability (post-vaccination 2) Number Analyzed 110 participants
7
   6.4%
Grade 3 Irritability (post-vaccination 2) Number Analyzed 110 participants
1
   0.9%
4.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
Hide Description Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.4 degree Celsius; Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius; Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Arm/Group Title Menactra® Vaccine (2 to 55 Years)
Hide Arm/Group Description:
Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fever
5
   4.5%
Grade 3 Fever
1
   0.9%
Any Headache
17
  15.2%
Grade 3 Headache
3
   2.7%
Any Malaise
24
  21.4%
Grade 3 Malaise
1
   0.9%
Any Myalgia
20
  17.9%
Grade 3 Myalgia
1
   0.9%
Time Frame Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age).
Adverse Event Reporting Description A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
 
Arm/Group Title Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years)
Hide Arm/Group Description Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1). Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
All-Cause Mortality
Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   0/112 (0.00%) 
Hide Serious Adverse Events
Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years)
Affected / at Risk (%) Affected / at Risk (%)
Total   16/112 (14.29%)   0/112 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1  1/112 (0.89%)  0/112 (0.00%) 
Infections and infestations     
Bronchiolitis † 1  3/112 (2.68%)  0/112 (0.00%) 
Diarrhoea infectious † 1  1/112 (0.89%)  0/112 (0.00%) 
Gastrointestinal infection † 1  1/112 (0.89%)  0/112 (0.00%) 
Hand-foot-and-mouth disease † 1  2/112 (1.79%)  0/112 (0.00%) 
Pneumonia † 1  3/112 (2.68%)  0/112 (0.00%) 
Respiratory tract infection † 1  1/112 (0.89%)  0/112 (0.00%) 
Tonsillitis † 1  1/112 (0.89%)  0/112 (0.00%) 
Viral infection † 1  2/112 (1.79%)  0/112 (0.00%) 
Nervous system disorders     
Febrile convulsion † 1  2/112 (1.79%)  0/112 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/112 (0.89%)  0/112 (0.00%) 
Respiratory tract inflammation † 1  1/112 (0.89%)  0/112 (0.00%) 
1
Term from vocabulary, MedDra 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menactra® Vaccine (9 to 23 Months) Menactra® Vaccine (2 to 55 Years)
Affected / at Risk (%) Affected / at Risk (%)
Total   86/112 (76.79%)   49/112 (43.75%) 
Gastrointestinal disorders     
Gastrointestinal disorder † 1  13/112 (11.61%)  0/112 (0.00%) 
Vomiting † 1  18/112 (16.07%)  1/112 (0.89%) 
General disorders     
Crying † 1  15/112 (13.39%)  0/112 (0.00%) 
Injection site pain † 1  23/112 (20.54%)  28/112 (25.00%) 
Malaise † 1  0/112 (0.00%)  24/112 (21.43%) 
Pyrexia † 1  24/112 (21.43%)  7/112 (6.25%) 
Infections and infestations     
Bronchiolitis † 1  11/112 (9.82%)  0/112 (0.00%) 
Bronchitis † 1  8/112 (7.14%)  1/112 (0.89%) 
Nasopharyngitis † 1  24/112 (21.43%)  0/112 (0.00%) 
Pharyngitis † 1  6/112 (5.36%)  4/112 (3.57%) 
Respiratory tract infection † 1  12/112 (10.71%)  0/112 (0.00%) 
Upper respiratory tract infection † 1  12/112 (10.71%)  3/112 (2.68%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  32/112 (28.57%)  0/112 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia † 1  0/112 (0.00%)  20/112 (17.86%) 
Nervous system disorders     
Headache † 1  0/112 (0.00%)  17/112 (15.18%) 
Somnolence † 1  8/112 (7.14%)  0/112 (0.00%) 
Psychiatric disorders     
Irritability † 1  16/112 (14.29%)  0/112 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  9/112 (8.04%)  3/112 (2.68%) 
Rhinorrhoea † 1  9/112 (8.04%)  2/112 (1.79%) 
1
Term from vocabulary, MedDra 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02640404    
Other Study ID Numbers: MTA90
U1111-1143-9207 ( Other Identifier: WHO )
First Submitted: December 22, 2015
First Posted: December 29, 2015
Results First Submitted: December 6, 2017
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018