Trial Outcomes & Findings for Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 (NCT NCT00595309)
NCT ID: NCT00595309
Last Updated: 2014-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
at Month 12 after booster
Results posted on
2014-05-16
Participant Flow
subjects participating in preceeding study IC51-309 were contacted. First Subject In December 2007, Last Subject In March 2008; study sites: center of pharmacology and travel clinics
subjects participating in study IC51-309 without major Protocol Deviations
Participant milestones
| Measure |
IC51 Booster Group
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
Overall Study
STARTED
|
198
|
|
Overall Study
COMPLETED
|
194
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
IC51 Booster Group
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
planned vaccination against yellow fever
|
1
|
|
Overall Study
acute infection after V0
|
1
|
|
Overall Study
personal reason
|
1
|
Baseline Characteristics
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Baseline characteristics by cohort
| Measure |
IC51 Booster Group
n=198 Participants
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
197 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
103 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at Month 12 after boosterPopulation: Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination
Outcome measures
| Measure |
IC51 Booster Group
n=198 Participants
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
Seroconversion Rate
|
98.5 percent
Interval 95.6 to 99.5
|
SECONDARY outcome
Timeframe: up to Month 12 after boosterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at D28 and Month 6 after boosterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: D28, Month 6 and Month 12 after boosterOutcome measures
Outcome data not reported
Adverse Events
IC51 Booster Group
Serious events: 8 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 Booster Group
n=198 participants at risk
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
1/198 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.51%
1/198 • Number of events 1
|
|
Injury, poisoning and procedural complications
Open wound
|
0.51%
1/198 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.51%
1/198 • Number of events 1
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.51%
1/198 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.51%
1/198 • Number of events 1
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.51%
1/198 • Number of events 1
|
|
Surgical and medical procedures
Breast Cosmetic Surgery
|
0.51%
1/198 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.51%
1/198 • Number of events 1
|
Other adverse events
| Measure |
IC51 Booster Group
n=198 participants at risk
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
|
|---|---|
|
General disorders
Fatigue
|
7.1%
14/198
|
|
General disorders
Influenza Like Illnes
|
9.6%
19/198
|
|
Infections and infestations
Nasopharyngitis
|
15.2%
30/198
|
|
Nervous system disorders
Headache
|
11.1%
22/198
|
|
Blood and lymphatic system disorders
Hypochronic Anaemia
|
1.0%
2/198
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.0%
4/198
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
4/198
|
|
Gastrointestinal disorders
Nausea
|
3.0%
6/198
|
|
General disorders
Pyrexia
|
2.5%
5/198
|
|
Immune system disorders
Allergy To Animal
|
1.0%
2/198
|
|
Infections and infestations
Acute Tonsillitis
|
1.0%
2/198
|
|
Infections and infestations
Bronchitis
|
3.5%
7/198
|
|
Infections and infestations
Cystitis
|
2.0%
4/198
|
|
Infections and infestations
Gastroenteritis
|
3.0%
6/198
|
|
Infections and infestations
Influenza
|
1.0%
2/198
|
|
Infections and infestations
Pharyngitis
|
1.0%
2/198
|
|
Infections and infestations
Rhinitis
|
1.0%
2/198
|
|
Infections and infestations
Sinusitis
|
1.0%
2/198
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
2/198
|
|
Injury, poisoning and procedural complications
Limb Injury
|
1.0%
2/198
|
|
Investigations
Alanine Aminotransferase Increased
|
1.0%
2/198
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
3/198
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
10/198
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.0%
2/198
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
5/198
|
|
Vascular disorders
Haematoma
|
1.0%
2/198
|
|
Vascular disorders
Hypertension
|
1.5%
3/198
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER