Trial Outcomes & Findings for Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune® (NCT NCT00258856)
NCT ID: NCT00258856
Last Updated: 2014-02-14
Results Overview
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
7 or 14 days post-vaccination
Results posted on
2014-02-14
Participant Flow
Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.
A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Menactra® Group 1
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination
|
Menactra® Group 2
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
|
Meningococcal Vaccine-naïve Group 3
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
|
Meningococcal Vaccine-naïve Group 4
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
58
|
59
|
|
Overall Study
COMPLETED
|
56
|
58
|
56
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Menactra® Group 1
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination
|
Menactra® Group 2
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
|
Meningococcal Vaccine-naïve Group 3
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
|
Meningococcal Vaccine-naïve Group 4
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
|
Overall Study
Non-compliance
|
2
|
0
|
0
|
1
|
Baseline Characteristics
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Baseline characteristics by cohort
| Measure |
Menactra® Group 1
n=59 Participants
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination
|
Menactra® Group 2
n=58 Participants
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
|
Meningococcal Vaccine-naïve Group 3
n=58 Participants
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
|
Meningococcal Vaccine-naïve Group 4
n=59 Participants
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 2.56 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 2.60 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 2.27 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 2.06 • n=4 Participants
|
11.0 years
STANDARD_DEVIATION 2.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
58 participants
n=7 Participants
|
58 participants
n=5 Participants
|
59 participants
n=4 Participants
|
234 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 or 14 days post-vaccinationPopulation: Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Outcome measures
| Measure |
Menactra® Group 1
n=56 Participants
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination
|
Menactra® Group 2
n=58 Participants
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
|
Meningococcal Vaccine-naïve Group 3
n=56 Participants
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
|
Meningococcal Vaccine-naïve Group 4
n=58 Participants
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup A - PRE
|
84 Percentage of participants
|
89 Percentage of participants
|
47 Percentage of participants
|
59 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup A - POST
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup C - PRE
|
62 Percentage of participants
|
58 Percentage of participants
|
39 Percentage of participants
|
47 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup C - POST
|
100 Percentage of participants
|
100 Percentage of participants
|
98 Percentage of participants
|
96 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup Y - PRE
|
96 Percentage of participants
|
96 Percentage of participants
|
87 Percentage of participants
|
98 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup Y - POST
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup W-135 - PRE
|
81 Percentage of participants
|
84 Percentage of participants
|
31 Percentage of participants
|
36 Percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Meningococcal serogroup W-135 - POST
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
98 Percentage of participants
|
Adverse Events
Menactra® Group 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Menactra® Group 2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Meningococcal Vaccine-naïve Group 3
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Meningococcal Vaccine-naïve Group 4
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menactra® Group 1
n=58 participants at risk
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination
|
Menactra® Group 2
n=58 participants at risk
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
|
Meningococcal Vaccine-naïve Group 3
n=58 participants at risk
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
|
Meningococcal Vaccine-naïve Group 4
n=59 participants at risk
Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
8.6%
5/58 • Number of events 6 • 28 days post-vaccination
|
8.6%
5/58 • Number of events 5 • 28 days post-vaccination
|
1.7%
1/59 • Number of events 1 • 28 days post-vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
8.5%
5/59 • Number of events 5 • 28 days post-vaccination
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
3.4%
2/59 • Number of events 2 • 28 days post-vaccination
|
|
General disorders
Pyrexia
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
1.7%
1/58 • Number of events 2 • 28 days post-vaccination
|
5.1%
3/59 • Number of events 3 • 28 days post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
0.00%
0/59 • 28 days post-vaccination
|
|
Infections and infestations
Otitis media
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
0.00%
0/59 • 28 days post-vaccination
|
|
Infections and infestations
Rhinitis
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
0.00%
0/58 • 28 days post-vaccination
|
1.7%
1/59 • Number of events 1 • 28 days post-vaccination
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 2 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 4 • 28 days post-vaccination
|
5.1%
3/59 • Number of events 3 • 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/58 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
6.9%
4/58 • Number of events 4 • 28 days post-vaccination
|
5.1%
3/59 • Number of events 3 • 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
6.9%
4/58 • Number of events 4 • 28 days post-vaccination
|
6.8%
4/59 • Number of events 4 • 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.7%
1/58 • Number of events 1 • 28 days post-vaccination
|
3.4%
2/58 • Number of events 2 • 28 days post-vaccination
|
5.2%
3/58 • Number of events 3 • 28 days post-vaccination
|
3.4%
2/59 • Number of events 2 • 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