Trial Outcomes & Findings for Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine (NCT NCT00772070)
NCT ID: NCT00772070
Last Updated: 2014-02-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
173 participants
Primary outcome timeframe
Day 0 and Days 8 and 28 post-vaccination
Results posted on
2014-02-14
Participant Flow
Study participants were enrolled from 10 march through 13 June 2003 in 8 US clinic sites
A total of 173 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Previously Received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
71
|
|
Overall Study
COMPLETED
|
100
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
Reasons for withdrawal
| Measure |
Previously Received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Vaccination error-wrong dose/expired lot
|
2
|
0
|
Baseline Characteristics
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
Previously Received TetraMenD
n=100 Participants
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
n=71 Participants
Participants have never received a Meningococcal vaccine in the past.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
171.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.5 years
STANDARD_DEVIATION 0.52 • n=5 Participants
|
3.8 years
STANDARD_DEVIATION 0.87 • n=7 Participants
|
4.2 years
STANDARD_DEVIATION 0.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
85.0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
71 participants
n=7 Participants
|
171.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Days 8 and 28 post-vaccinationPopulation: Geometric mean titers were determined in the per-protocol population.
Outcome measures
| Measure |
Previously Received TetraMenD
n=100 Participants
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
n=61 Participants
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup A (Day 0)
|
316.1 Titers
Interval 182.6 to 547.2
|
126.5 Titers
Interval 67.3 to 237.9
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup A (Day 8)
|
11411.9 Titers
Interval 9196.5 to 14161.1
|
6720.1 Titers
Interval 5205.0 to 8676.2
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup A (Day 28)
|
5620.6 Titers
Interval 4321.2 to 7310.8
|
2603.3 Titers
Interval 1767.0 to 3835.3
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup C (Day 0)
|
68.4 Titers
Interval 41.2 to 113.6
|
21.2 Titers
Interval 11.6 to 38.9
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup C (Day 8)
|
8700.9 Titers
Interval 6185.5 to 12239.1
|
2447.5 Titers
Interval 1651.9 to 3626.3
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup C (Day 28)
|
7261.6 Titers
Interval 5213.5 to 10114.4
|
300.4 Titers
Interval 128.8 to 700.4
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup Y (Day 0)
|
411.5 Titers
Interval 286.9 to 590.1
|
241.8 Titers
Interval 138.3 to 422.9
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup Y (Day 8)
|
7261.6 Titers
Interval 5696.2 to 9257.2
|
3859.7 Titers
Interval 2751.1 to 5414.9
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup Y (Day 28)
|
3798.7 Titers
Interval 2735.7 to 5274.8
|
1410.0 Titers
Interval 939.9 to 2115.3
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup W-135 (Day 0)
|
92.5 Titers
Interval 57.9 to 147.8
|
17.5 Titers
Interval 10.8 to 28.2
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup W-135 (Day 8)
|
11761.1 Titers
Interval 8556.4 to 16166.0
|
5194.8 Titers
Interval 3849.3 to 7010.5
|
|
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Meningococcal Serogroup W-135 (Day 28)
|
6245.9 Titers
Interval 4231.8 to 9218.5
|
2103.3 Titers
Interval 1303.7 to 3393.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 8 and Day 28 post-vaccinationPopulation: Fold rise analysis was assessed in per-protocol population with valid serology data.
Outcome measures
| Measure |
Previously Received TetraMenD
n=46 Participants
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
n=35 Participants
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup A (Day 8)
|
93 Percentage of participants
|
89 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup C (Day 8)
|
91 Percentage of participants
|
89 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup Y (Day 8)
|
96 Percentage of participants
|
74 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup W-135 (Day 8)
|
98 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup A (Day 28)
|
72 Percentage of participants
|
85 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup C (Day 28)
|
93 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup Y (Day 28)
|
78 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Meningococcal Serogroup W-135 (Day 28)
|
93 Percentage of participants
|
100 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
Outcome measures
| Measure |
Previously Received TetraMenD
n=100 Participants
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
n=69 Participants
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Solicited Local Reaction (Days 0-7)
|
46 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Grade 3 Solicited Local Reaction (Days 0-7)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Redness
|
23 Percentage of participants
|
20 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Redness (>2 inch)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Swelling
|
11 Percentage of participants
|
15 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Swelling (>2 inch)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Induration
|
14 Percentage of participants
|
13 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Induration (>2 inch)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Pain
|
34 Percentage of participants
|
33 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Pain (Disabling, unable to move arm)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Solicited Systemic Reaction (Days 0-7)
|
38 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Grade 3 Solicited Systemic Reaction (Days 0-7)
|
3 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Fever
|
10 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Fever (≥ 40.0°C)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Fussiness
|
22 Percentage of participants
|
30 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Fussiness (Irritability for > 3 hours)
|
1 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Drowsiness
|
17 Percentage of participants
|
12 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grd 3 Drowsiness: not interested in usual activity
|
1 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Anorexia
|
8 Percentage of participants
|
13 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Anorexia (Skipped ≥ 3 meals)
|
1 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Vomiting
|
5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Vomiting (≥ 3 episodes)
|
2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Any Diarrhea
|
6 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Grade 3 Diarrhea (≥ 5 episodes)
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Previously Received TetraMenD
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Meningococcal Vaccine-naive
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Previously Received TetraMenD
n=100 participants at risk
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
|
Meningococcal Vaccine-naive
n=71 participants at risk
Participants have never received a Meningococcal vaccine in the past.
|
|---|---|---|
|
General disorders
Injection site erythema
|
23.0%
23/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
29.0%
20/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
General disorders
Injection site swelling
|
11.0%
11/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
21.7%
15/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
General disorders
Injection site Induration
|
14.0%
14/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
18.8%
13/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
General disorders
Injection site pain
|
34.0%
34/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
47.8%
33/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
General disorders
Pyrexia
|
10.0%
10/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
4.3%
3/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Gastrointestinal disorders
Vomiting NOS
|
5.0%
5/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
0.00%
0/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Nervous system disorders
Somnolence
|
17.0%
17/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
17.4%
12/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
8/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
18.8%
13/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Psychiatric disorders
Irritability
|
22.0%
22/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
43.5%
30/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
6/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
13.0%
9/69 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
3/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
5.6%
4/71 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
9/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
4.2%
3/71 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
6/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
2.8%
2/71 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
5/100 • Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
|
1.4%
1/71 • Adverse events data were collected from the day of vaccination 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