Trial Outcomes & Findings for Immunology and Safety of Menactra® in Children in Saudi Arabia (NCT NCT00539032)
NCT ID: NCT00539032
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.
A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1: Menactra® Booster Group
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
85
|
|
Overall Study
COMPLETED
|
151
|
84
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Menactra® Booster Group
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Immunology and Safety of Menactra® in Children in Saudi Arabia
Baseline characteristics by cohort
| Measure |
Group 1: Menactra® Booster Group
n=153 Participants
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=85 Participants
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
153 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.12 Years
STANDARD_DEVIATION 0.60 • n=5 Participants
|
6.52 Years
STANDARD_DEVIATION 1.22 • n=7 Participants
|
6.26 Years
STANDARD_DEVIATION 0.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
153 participants
n=5 Participants
|
85 participants
n=7 Participants
|
238 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccinationPopulation: Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® Booster Group
n=140 Participants
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=81 Participants
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup A: Pre-vaccination
|
168.9 Titers
Interval 117.4 to 243.1
|
196.4 Titers
Interval 119.0 to 324.0
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup A: Day 28 Post-vaccination
|
6991.7 Titers
Interval 6107.6 to 8003.8
|
8263.3 Titers
Interval 6913.1 to 9877.2
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup C: Pre-vaccination
|
2.5 Titers
Interval 2.2 to 3.0
|
4.1 Titers
Interval 2.8 to 5.9
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup C: Day 28 Post-vaccination
|
167.2 Titers
Interval 115.3 to 242.7
|
512.0 Titers
Interval 334.4 to 761.2
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup Y: Pre-vaccination
|
10.2 Titers
Interval 6.8 to 15.2
|
12.4 Titers
Interval 7.1 to 21.6
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup Y: Day 28 Post-vaccination
|
2120.2 Titers
Interval 1799.0 to 2498.9
|
2558.3 Titers
Interval 2015.5 to 3247.3
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup W-135: Pre-vaccination
|
3.0 Titers
Interval 2.4 to 3.8
|
2.7 Titers
Interval 2.1 to 3.5
|
|
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Serogroup W-135: Day 28 Post-vaccination
|
2387.7 Titers
Interval 1950.1 to 2923.5
|
2763.2 Titers
Interval 2153.9 to 3544.8
|
PRIMARY outcome
Timeframe: Day 28 Post-vaccinationPopulation: 4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® Booster Group
n=140 Participants
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=81 Participants
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Serogroup A
|
94 Percentage of Participants
|
94 Percentage of Participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Serogroup C
|
84 Percentage of Participants
|
90 Percentage of Participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Serogroup Y
|
97 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Serogroup W-135
|
99 Percentage of Participants
|
100 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0-7 Post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.
Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.
Outcome measures
| Measure |
Group 1: Menactra® Booster Group
n=151 Participants
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=85 Participants
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Pain
|
32 Participants
|
15 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Malaise
|
18 Participants
|
11 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Solicited Injection Site Reaction
|
35 Participants
|
19 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Pain (Incapacitating)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Erythema
|
10 Participants
|
8 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Erythema (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Swelling
|
11 Participants
|
8 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Swelling (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Solicited Systemic Reaction
|
36 Participants
|
16 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Fever
|
16 Participants
|
8 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Fever (> 39.0 ºC)
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Headache
|
13 Participants
|
5 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Headache (Prevents daily activities)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Malaise (Prevents daily activities)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Any Myalgia
|
21 Participants
|
10 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Grade 3 Myalgia (Prevents daily activities)
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Menactra® Booster Group
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Group 2: Menactra® Primary Vaccine (Control) Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Menactra® Booster Group
n=151 participants at risk
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=85 participants at risk
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.66%
1/151 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
0.00%
0/85 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
Infections and infestations
Postoperative wound infections
|
0.66%
1/151 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
0.00%
0/85 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
Other adverse events
| Measure |
Group 1: Menactra® Booster Group
n=151 participants at risk
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
|
Group 2: Menactra® Primary Vaccine (Control) Group
n=85 participants at risk
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
|
|---|---|---|
|
General disorders
Injection site pain
|
21.2%
32/151 • Number of events 32 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
17.6%
15/85 • Number of events 15 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
General disorders
Injection site erythema
|
6.6%
10/151 • Number of events 10 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
9.4%
8/85 • Number of events 8 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
General disorders
Injection site swelling
|
7.3%
11/151 • Number of events 11 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
9.4%
8/85 • Number of events 8 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
General disorders
Pyrexia
|
10.6%
16/151 • Number of events 16 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
9.4%
8/85 • Number of events 8 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
Nervous system disorders
Headache
|
8.6%
13/151 • Number of events 13 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
5.9%
5/85 • Number of events 5 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
General disorders
Malaise
|
11.9%
18/151 • Number of events 18 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
12.9%
11/85 • Number of events 11 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
|
General disorders
Myalgia
|
13.9%
21/151 • Number of events 21 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
11.8%
10/85 • Number of events 10 • Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER