Trial Outcomes & Findings for Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia (NCT NCT00444951)
NCT ID: NCT00444951
Last Updated: 2015-07-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
450 participants
Primary outcome timeframe
Baseline (Day 0) and Day 28 after vaccination
Results posted on
2015-07-14
Participant Flow
Participants were enrolled from 17 February 2007, to 01 July 2007, in 7 clinic centers in Saudi Arabia.
A total of 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.
Participant milestones
| Measure |
Menactra® Group
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
145
|
142
|
163
|
|
Overall Study
COMPLETED
|
140
|
136
|
160
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
3
|
Reasons for withdrawal
| Measure |
Menactra® Group
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
3
|
Baseline Characteristics
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Baseline characteristics by cohort
| Measure |
Menactra® Group
n=145 Participants
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=142 Participants
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=163 Participants
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
110 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
17.90 Years
STANDARD_DEVIATION 1.20 • n=5 Participants
|
17.77 Years
STANDARD_DEVIATION 1.15 • n=7 Participants
|
17.85 Years
STANDARD_DEVIATION 1.15 • n=5 Participants
|
17.84 Years
STANDARD_DEVIATION 1.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Region of Enrollment
Saudi Arabia
|
145 participants
n=5 Participants
|
142 participants
n=7 Participants
|
163 participants
n=5 Participants
|
450 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Day 28 after vaccinationPopulation: Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).
Outcome measures
| Measure |
Menactra® Group
n=144 Participants
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=141 Participants
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=161 Participants
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup A (Baseline)
|
651.5 Titers (1/dil)
Interval 496.4 to 854.9
|
889.7 Titers (1/dil)
Interval 699.5 to 1131.5
|
441.1 Titers (1/dil)
Interval 327.8 to 593.4
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup A (Day 28)
|
4116.3 Titers (1/dil)
Interval 3468.7 to 4884.9
|
3833.4 Titers (1/dil)
Interval 3308.4 to 4441.7
|
6351.6 Titers (1/dil)
Interval 5508.3 to 7324.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup C (Baseline)
|
14.7 Titers (1/dil)
Interval 9.9 to 22.0
|
15.8 Titers (1/dil)
Interval 10.4 to 23.8
|
16.8 Titers (1/dil)
Interval 11.1 to 25.4
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup C (Day 28)
|
288.3 Titers (1/dil)
Interval 190.2 to 437.0
|
158.6 Titers (1/dil)
Interval 99.7 to 252.0
|
993.4 Titers (1/dil)
Interval 714.5 to 1381.2
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup Y (Baseline)
|
78.8 Titers (1/dil)
Interval 49.7 to 125.0
|
73.4 Titers (1/dil)
Interval 44.7 to 120.7
|
16.8 Titers (1/dil)
Interval 11.1 to 25.3
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup Y (Day 28)
|
2770.1 Titers (1/dil)
Interval 2197.0 to 3492.6
|
1936.3 Titers (1/dil)
Interval 1425.7 to 2629.8
|
4204.6 Titers (1/dil)
Interval 3458.2 to 5112.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup W-135 (Baseline)
|
18.5 Titers (1/dil)
Interval 11.8 to 29.0
|
24.5 Titers (1/dil)
Interval 15.2 to 39.6
|
8.1 Titers (1/dil)
Interval 5.6 to 11.8
|
|
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Serogroup W-135 (Day 28)
|
2435.5 Titers (1/dil)
Interval 1714.7 to 3459.3
|
1455.7 Titers (1/dil)
Interval 958.1 to 2211.7
|
6926.7 Titers (1/dil)
Interval 5647.9 to 8495.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 28 After VaccinationPopulation: 4-Fold rise titers were determined in the per-protocol population.
Outcome measures
| Measure |
Menactra® Group
n=140 Participants
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=136 Participants
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=160 Participants
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Serogroup Y
|
80 Percentage of Participants
|
69 Percentage of Participants
|
96 Percentage of Participants
|
|
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Serogroup W-135
|
84 Percentage of Participants
|
72 Percentage of Participants
|
96 Percentage of Participants
|
|
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Serogroup A
|
66 Percentage of Participants
|
62 Percentage of Participants
|
86 Percentage of Participants
|
|
Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Serogroup C
|
71 Percentage of Participants
|
57 Percentage of Participants
|
81 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 7 Post-vaccinationPopulation: Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)
Outcome measures
| Measure |
Menactra® Group
n=144 Participants
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=141 Participants
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=160 Participants
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Fever
|
25 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Fever (> 39.0 ºC)
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Solicited Injection Site Reaction
|
88 Participants
|
71 Participants
|
98 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Injection Site Pain
|
85 Participants
|
66 Participants
|
95 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Injection Site Pain (Incapacitating)
|
10 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Injection Site Erythema
|
39 Participants
|
34 Participants
|
42 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Injection Site Erythema (≥ 5 cm)
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Injection Site Swelling
|
46 Participants
|
29 Participants
|
34 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Injection Site Swelling (≥ 5 cm)
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Solicited Systemic Reaction
|
87 Participants
|
86 Participants
|
90 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Headache
|
66 Participants
|
64 Participants
|
60 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Headache (Prevents daily activities)
|
8 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Malaise
|
61 Participants
|
55 Participants
|
61 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Malaise (Prevents daily activities)
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Any Myalgia
|
60 Participants
|
55 Participants
|
72 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Grade 3 Myalgia (Prevents daily activities)
|
10 Participants
|
8 Participants
|
10 Participants
|
Adverse Events
Menactra® Group
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Mencevax® Group
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra® Group
n=144 participants at risk
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=141 participants at risk
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=160 participants at risk
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
Infections and infestations
Perianal abcess
|
0.69%
1/144 • Number of events 1 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
0.00%
0/141 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
0.00%
0/160 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
Other adverse events
| Measure |
Menactra® Group
n=144 participants at risk
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
|
Mencevax® Group
n=141 participants at risk
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
|
Control Group
n=160 participants at risk
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
|
|---|---|---|---|
|
General disorders
Injection site pain
|
59.9%
85/142 • Number of events 85 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
47.8%
66/138 • Number of events 66 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
60.1%
95/158 • Number of events 95 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
General disorders
Injection site erythema
|
27.5%
39/142 • Number of events 39 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
24.6%
34/138 • Number of events 34 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
26.6%
42/158 • Number of events 42 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
General disorders
Injection site swelling
|
32.4%
46/142 • Number of events 46 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
21.0%
29/138 • Number of events 29 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
21.5%
34/158 • Number of events 34 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
General disorders
Fever
|
17.6%
25/142 • Number of events 25 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
12.3%
17/138 • Number of events 17 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
10.1%
16/158 • Number of events 16 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
Nervous system disorders
Headache
|
46.5%
66/142 • Number of events 66 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
46.4%
64/138 • Number of events 64 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
38.0%
60/158 • Number of events 60 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
Gastrointestinal disorders
Malaise
|
43.0%
61/142 • Number of events 61 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
39.9%
55/138 • Number of events 55 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
38.6%
61/158 • Number of events 61 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.3%
60/142 • Number of events 60 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
39.9%
55/138 • Number of events 55 • Adverse event data were collected from Day 0 to 1 month post-vaccination
|
45.6%
72/158 • Number of events 72 • Adverse event data were collected from Day 0 to 1 month 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