Trial Outcomes & Findings for Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children (NCT NCT00771849)
NCT ID: NCT00771849
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Day 0 (before) and 28 days post-vaccination
Results posted on
2016-04-14
Participant Flow
Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.
A total of 103 subjects that met the inclusion but none of the exclusion criteria were enrolled, 102 subjects were vaccinated.
Participant milestones
| Measure |
Menactra® Vaccine Group
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Menactra® Vaccine Group
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Not vaccinated
|
0
|
1
|
Baseline Characteristics
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
Baseline characteristics by cohort
| Measure |
Menactra® Vaccine Group
n=52 Participants
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
n=51 Participants
Participants received Hiberix® Vaccine
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 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
|
37.0 Months
STANDARD_DEVIATION 8.5 • n=5 Participants
|
37.6 Months
STANDARD_DEVIATION 8.3 • n=7 Participants
|
37.3 Months
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (before) and 28 days post-vaccinationPopulation: SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=44 Participants
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
n=36 Participants
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup A - Day 0
|
136.33 Titers
Interval 69.39 to 267.84
|
99.66 Titers
Interval 47.66 to 208.4
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup A - Day 28
|
11404.16 Titers
Interval 7383.63 to 17613.96
|
199.31 Titers
Interval 93.14 to 426.52
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup C - Day 0
|
76.11 Titers
Interval 36.57 to 158.41
|
26.91 Titers
Interval 12.49 to 57.97
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup C - Day 28
|
12534.67 Titers
Interval 8407.56 to 18687.71
|
22.63 Titers
Interval 10.5 to 48.76
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup Y - Day 0
|
236.61 Titers
Interval 133.11 to 420.6
|
266.05 Titers
Interval 151.05 to 468.59
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup Y - Day 28
|
4031.98 Titers
Interval 2399.1 to 6776.24
|
298.63 Titers
Interval 155.64 to 572.99
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup W-135 - Day 0
|
26.07 Titers
Interval 13.3 to 51.13
|
24.44 Titers
Interval 11.76 to 50.79
|
|
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Meningococcal Serogroup W-135 - Day 28
|
5978.03 Titers
Interval 3852.54 to 9276.19
|
32 Titers
Interval 16.33 to 62.71
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=44 Participants
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
n=36 Participants
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Meningococcal Serogroup A
|
43 Participants
|
11 Participants
|
|
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Meningococcal Serogroup C
|
41 Participants
|
2 Participants
|
|
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Meningococcal Serogroup Y
|
35 Participants
|
1 Participants
|
|
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Meningococcal Serogroup W-135
|
43 Participants
|
8 Participants
|
Adverse Events
Menactra® Vaccine Group
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Hiberix® Vaccine Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra® Vaccine Group
n=52 participants at risk
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
n=50 participants at risk
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
1.9%
1/52 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
0.00%
0/50 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
Other adverse events
| Measure |
Menactra® Vaccine Group
n=52 participants at risk
Participants received Menactra® Vaccine
|
Hiberix® Vaccine Group
n=50 participants at risk
Participants received Hiberix® Vaccine
|
|---|---|---|
|
Infections and infestations
Gastroenteritis NOS
|
0.00%
0/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
6.4%
3/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
|
Infections and infestations
Otitis media NOS
|
0.00%
0/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
6.4%
3/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
3.9%
2/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
6.4%
3/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
|
Gastrointestinal disorders
Pyrexia
|
2.0%
1/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
6.4%
3/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
19.6%
10/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
29.8%
14/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
6.4%
3/47 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
|
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