Trial Outcomes & Findings for Immunogenicity of the Booster Dose of Two MenC Vaccines (NCT NCT00392808)
NCT ID: NCT00392808
Last Updated: 2013-10-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
389 participants
Primary outcome timeframe
One month after booster dose
Results posted on
2013-10-11
Participant Flow
Recruitment was done in primary care pediatric clinics, between january and may 2007.
Participant milestones
| Measure |
MENC-TT/MENC-TT
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
89
|
109
|
104
|
|
Overall Study
COMPLETED
|
81
|
86
|
107
|
100
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
MENC-TT/MENC-TT
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
2
|
|
Overall Study
Unable to withdraw blood
|
3
|
1
|
1
|
2
|
Baseline Characteristics
Immunogenicity of the Booster Dose of Two MenC Vaccines
Baseline characteristics by cohort
| Measure |
MENC-CRM/MENC-CRM
n=104 Participants
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
n=109 Participants
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-TT/MENC-CRM
n=89 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-TT/MENC-TT
n=87 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
104 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
389 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
|
1.37 years
STANDARD_DEVIATION 0.23 • n=5 Participants
|
1.38 years
STANDARD_DEVIATION 0.13 • n=7 Participants
|
1.43 years
STANDARD_DEVIATION 0.23 • n=5 Participants
|
1.46 years
STANDARD_DEVIATION 0.09 • n=4 Participants
|
1.4 years
STANDARD_DEVIATION .15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
187 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
104 participants
n=5 Participants
|
109 participants
n=7 Participants
|
89 participants
n=5 Participants
|
87 participants
n=4 Participants
|
389 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One month after booster doseOutcome measures
| Measure |
MENC-TT/MENC-TT
n=81 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
n=86 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
n=107 Participants
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
n=100 Participants
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Serum Bactericidal Activity Against MenC
|
6786 GMTs
Interval 5023.0 to 9167.0
|
6278 GMTs
Interval 5359.0 to 7932.0
|
2061 GMTs
Interval 1599.0 to 2627.0
|
1746 GMTs
Interval 1378.0 to 2213.0
|
PRIMARY outcome
Timeframe: One yearOutcome measures
| Measure |
MENC-TT/MENC-TT
n=76 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
n=79 Participants
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
n=83 Participants
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
n=79 Participants
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Serum Antibody Titers Against Haemophilus Influenzae Type b.
|
23.8 GMCs
Interval 17.5 to 32.4
|
30.8 GMCs
Interval 23.7 to 40.1
|
30.5 GMCs
Interval 23.3 to 40.0
|
26.0 GMCs
Interval 19.1 to 35.4
|
Adverse Events
MENC-TT/MENC-TT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
MENC-TT/MENC-CRM
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
MENC-CRM/MENC-TT
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
MENC-CRM/MENC-CRM
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MENC-TT/MENC-TT
n=87 participants at risk
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
n=89 participants at risk
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
n=109 participants at risk
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
n=104 participants at risk
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Nervous system disorders
Febrile seizures
|
1.1%
1/87 • Number of events 1
|
1.1%
1/89 • Number of events 2
|
0.00%
0/109
|
0.00%
0/104
|
|
General disorders
cutaneous abscess
|
1.1%
1/87 • Number of events 1
|
0.00%
0/89
|
0.00%
0/109
|
0.00%
0/104
|
|
Nervous system disorders
ataxia
|
1.1%
1/87 • Number of events 1
|
0.00%
0/89
|
0.00%
0/109
|
0.00%
0/104
|
|
Infections and infestations
pneumonia
|
0.00%
0/87
|
1.1%
1/89 • Number of events 1
|
0.00%
0/109
|
0.00%
0/104
|
|
Infections and infestations
Leishmaniasis
|
0.00%
0/87
|
1.1%
1/89 • Number of events 1
|
0.00%
0/109
|
0.00%
0/104
|
|
General disorders
asthma
|
0.00%
0/87
|
2.2%
2/89 • Number of events 2
|
0.00%
0/109
|
0.00%
0/104
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/87
|
0.00%
0/89
|
0.92%
1/109 • Number of events 1
|
0.00%
0/104
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/87
|
0.00%
0/89
|
0.92%
1/109 • Number of events 1
|
0.00%
0/104
|
|
General disorders
fever
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/109
|
1.9%
2/104 • Number of events 2
|
Other adverse events
| Measure |
MENC-TT/MENC-TT
n=87 participants at risk
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
|
MENC-TT/MENC-CRM
n=89 participants at risk
Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
|
MENC-CRM/MENC-TT
n=109 participants at risk
Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
|
MENC-CRM/MENC-CRM
n=104 participants at risk
Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
local reactions: pain, induration
|
0.00%
0/87
|
0.00%
0/89
|
4.6%
5/109 • Number of events 5
|
4.8%
5/104 • Number of events 5
|
|
General disorders
fever
|
0.00%
0/87
|
0.00%
0/89
|
0.92%
1/109 • Number of events 1
|
0.96%
1/104 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/87
|
1.1%
1/89 • Number of events 1
|
0.00%
0/109
|
0.00%
0/104
|
|
Skin and subcutaneous tissue disorders
acropustulosis
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/109
|
0.96%
1/104 • Number of events 1
|
Additional Information
Javier Diez-Domingo
Centro Superior de Investigacion en Salud Publica
Phone: +34961925937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place