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Trial Outcomes & Findings for Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 (NCT NCT00595270)

NCT ID: NCT00595270

Last Updated: 2014-03-07

Results Overview

Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: * pos. (positive) (persistent): Subjects * with a non-missing, pos. seroconversion at D56 (Study IC51-304) and * without booster at M11 or M23 and * with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and * with non-missing, SP pos. PRNT50 at M24 * neg. (negative) (non-persistent): Subjects with * missing or neg. seroconversion at D56 (Study IC51-304) or * booster at M11 or at M23, or * non-missing, SP neg. PRNT50 at M6 or M12 or * missing PRNT50 at both M6 and M12 or * missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

349 participants

Primary outcome timeframe

- 24 months

Results posted on

2014-03-07

Participant Flow

Participant milestones

Participant milestones
Measure
IC51 2 x 6 µg
treatment group in preceeding study IC51-304
IC51 1 x 12 µg
treatment group in preceeding study IC51-304
IC51 1 x 6 µg
treatment group in preceeding study IC51-304
Overall Study
STARTED
116
117
116
Overall Study
COMPLETED
110
107
108
Overall Study
NOT COMPLETED
6
10
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IC51 2 x 6 µg
n=116 Participants
treatment group in preceeding study IC51-304
IC51 1 x 12 µg
n=117 Participants
treatment group in preceeding study IC51-304
IC51 1 x 6 µg
n=116 Participants
treatment group in preceeding study IC51-304
Total
n=349 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
109 Participants
n=5 Participants
108 Participants
n=7 Participants
106 Participants
n=5 Participants
323 Participants
n=4 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
9 Participants
n=7 Participants
10 Participants
n=5 Participants
26 Participants
n=4 Participants
Sex: Female, Male
Female
67 Participants
n=5 Participants
60 Participants
n=7 Participants
57 Participants
n=5 Participants
184 Participants
n=4 Participants
Sex: Female, Male
Male
49 Participants
n=5 Participants
57 Participants
n=7 Participants
59 Participants
n=5 Participants
165 Participants
n=4 Participants
Region of Enrollment
Europe
116 participants
n=5 Participants
117 participants
n=7 Participants
116 participants
n=5 Participants
349 participants
n=4 Participants

PRIMARY outcome

Timeframe: - 24 months

Population: ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304

Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: * pos. (positive) (persistent): Subjects * with a non-missing, pos. seroconversion at D56 (Study IC51-304) and * without booster at M11 or M23 and * with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and * with non-missing, SP pos. PRNT50 at M24 * neg. (negative) (non-persistent): Subjects with * missing or neg. seroconversion at D56 (Study IC51-304) or * booster at M11 or at M23, or * non-missing, SP neg. PRNT50 at M6 or M12 or * missing PRNT50 at both M6 and M12 or * missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24

Outcome measures

Outcome measures
Measure
IC51 2 x 6 µg
n=116 Participants
treatment group in preceeding study IC51-304
IC51 1 x 12 µg
n=117 Participants
treatment group in preceeding study IC51-304
IC51 1 x 6 µg
n=116 Participants
treatment group in preceeding study IC51-304
Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
56 percentage of participants
Interval 39.4 to 57.3
7 percentage of participants
Interval 3.0 to 11.9
5 percentage of participants
Interval 1.8 to 9.6

SECONDARY outcome

Timeframe: 24 months

Persistence of immunogenicity (SPR) at M24 (observed) defined as : * positive (persistent): Subjects * with a non-missing, positive seroconversion at D56 (Study IC51-304), and * who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and * with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and * with a non-missing, SP positive PRNT50 result at Visit 5 (M24) * negative (non-persistent): Subjects * with missing or negative seroconversion at D56 (Study IC51-304), or * who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or * with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or * with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or * with a non-missing, SP negative PRNT50 result at Visit 5 (M24)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: - 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: study duration

Outcome measures

Outcome data not reported

Adverse Events

IC51 2 x 6 µg

Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths

IC51 1 x 12 µg

Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths

IC51 1 x 6 µg

Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
IC51 2 x 6 µg
n=116 participants at risk
treatment group in preceeding study IC51-304
IC51 1 x 12 µg
n=117 participants at risk
treatment group in preceeding study IC51-304
IC51 1 x 6 µg
n=116 participants at risk
treatment group in preceeding study IC51-304
Infections and infestations
Appendicitis
0.86%
1/116
0.00%
0/117
0.00%
0/116
Injury, poisoning and procedural complications
Facial Bones Fracture
0.00%
0/116
0.85%
1/117
0.00%
0/116
Injury, poisoning and procedural complications
Hand Fracture
0.00%
0/116
0.00%
0/117
0.86%
1/116
Injury, poisoning and procedural complications
Tendon Injury
0.00%
0/116
0.85%
1/117
0.00%
0/116
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/116
0.85%
1/117
0.00%
0/116
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.86%
1/116
0.00%
0/117
0.00%
0/116
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
0.00%
0/116
0.00%
0/117
0.86%
1/116
Renal and urinary disorders
Urinary Incontinence
0.86%
1/116
0.00%
0/117
0.00%
0/116
Reproductive system and breast disorders
Uterine Prolapse
0.00%
0/116
0.00%
0/117
0.86%
1/116
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
0.86%
1/116
0.00%
0/117
0.00%
0/116
Surgical and medical procedures
Hysterectomy
0.00%
0/116
0.85%
1/117
0.00%
0/116

Other adverse events

Other adverse events
Measure
IC51 2 x 6 µg
n=116 participants at risk
treatment group in preceeding study IC51-304
IC51 1 x 12 µg
n=117 participants at risk
treatment group in preceeding study IC51-304
IC51 1 x 6 µg
n=116 participants at risk
treatment group in preceeding study IC51-304
General disorders
Fatique
4.3%
5/116
6.0%
7/117
5.2%
6/116
General disorders
Influenza Like Ilness
6.0%
7/116
4.3%
5/117
5.2%
6/116
Infections and infestations
Nasopharyngitis
10.3%
12/116
11.1%
13/117
9.5%
11/116
Nervous system disorders
Headache
8.6%
10/116
10.3%
12/117
11.2%
13/116
Gastrointestinal disorders
Diarrhoea
2.6%
3/116
2.6%
3/117
0.00%
0/116
Gastrointestinal disorders
Nausea
0.86%
1/116
5.1%
6/117
3.4%
4/116
Gastrointestinal disorders
Toothache
1.7%
2/116
0.85%
1/117
1.7%
2/116
Gastrointestinal disorders
Vomiting
1.7%
2/116
0.85%
1/117
0.86%
1/116
Infections and infestations
Sinusitis
2.6%
3/116
0.00%
0/117
0.86%
1/116
Injury, poisoning and procedural complications
Accidental Poisoning
0.86%
1/116
2.6%
3/117
0.00%
0/116
Musculoskeletal and connective tissue disorders
Back Pain
2.6%
3/116
3.4%
4/117
1.7%
2/116
Musculoskeletal and connective tissue disorders
Myalgia
0.86%
1/116
3.4%
4/117
4.3%
5/116
Reproductive system and breast disorders
Dysmenorrhoea
2.6%
3/116
0.85%
1/117
0.86%
1/116
Respiratory, thoracic and mediastinal disorders
Cough
4.3%
5/116
1.7%
2/117
1.7%
2/116
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
4.3%
5/116
4.3%
5/117
2.6%
3/116
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.86%
1/116
1.7%
2/117
1.7%
2/116
Skin and subcutaneous tissue disorders
Rash
1.7%
2/116
1.7%
2/117
3.4%
4/116
Blood and lymphatic system disorders
Anaemia
0.00%
0/116
0.00%
0/117
1.7%
2/116
Blood and lymphatic system disorders
Lymphadenopathy
1.7%
2/116
0.85%
1/117
0.00%
0/116
Gastrointestinal disorders
Abdominal Pain Upper
0.86%
1/116
1.7%
2/117
0.00%
0/116
General disorders
Induration
0.86%
1/116
0.00%
0/117
1.7%
2/116
General disorders
Injection Site Pain
0.00%
0/116
1.7%
2/117
0.86%
1/116
Infections and infestations
Herpes Zoster
0.86%
1/116
0.00%
0/117
1.7%
2/116
Infections and infestations
Lower Respiratory Tract Infection
1.7%
2/116
0.00%
0/117
0.86%
1/116
Infections and infestations
Pharyngitis
0.00%
0/116
0.00%
0/117
1.7%
2/116
Injury, poisoning and procedural complications
Procedural Pain
0.86%
1/116
1.7%
2/117
0.00%
0/116
Investigations
Haematocrit Decreased
0.00%
0/116
1.7%
2/117
0.00%
0/116
Investigations
Haemoglobin Decreased
0.00%
0/116
1.7%
2/117
0.00%
0/116
Investigations
Red Blood Cell Count Decreased
0.00%
0/116
1.7%
2/117
0.00%
0/116
Musculoskeletal and connective tissue disorders
Pain In Extremity
1.7%
2/116
0.00%
0/117
0.86%
1/116
Nervous system disorders
Hypoaesthesia
1.7%
2/116
0.00%
0/117
0.00%
0/116
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
0.00%
0/116
1.7%
2/117
0.00%
0/116
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
0.00%
0/116
1.7%
2/117
0.00%
0/116
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/116
0.00%
0/117
1.7%
2/116

Additional Information

Senior Manager Clinical Research

Intercell AG

Phone: +43 1 206 20

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER