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Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine

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ClinicalTrials.gov Identifier: NCT01567865
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : November 12, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Interventions Biological: Vaccine produced in existing facility
Biological: Vaccine produced in new facility
Enrollment 818
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3
Hide Arm/Group Description

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Period Title: Enrolled and Vaccinated (Day 0)
Started 163 220 211 224
Completed 163 220 211 224
Not Completed 0 0 0 0
Period Title: Evaluated for Immunogenicity
Started 163 220 211 224
Completed 146 195 192 194
Not Completed 17 25 19 30
Reason Not Completed
Sero+ for anti-JEV at Visit 1             0             1             3             2
Missing blood sample             17             24             16             28
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3 Total
Hide Arm/Group Description

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Total of all reporting groups
Overall Number of Baseline Participants 146 195 192 194 727
Hide Baseline Analysis Population Description
Per-protocol population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 146 participants 195 participants 192 participants 194 participants 727 participants
10.8  (.68) 10.9  (.73) 10.8  (.65) 10.9  (.7) 10.9  (.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 195 participants 192 participants 194 participants 727 participants
Female
76
  52.1%
100
  51.3%
92
  47.9%
98
  50.5%
366
  50.3%
Male
70
  47.9%
95
  48.7%
100
  52.1%
96
  49.5%
361
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 146 participants 195 participants 192 participants 194 participants 727 participants
146 195 192 194 727
1.Primary Outcome
Title Number/Percentage of Subjects With Demonstrated Seroprotection
Hide Description

Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control.

In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.

Time Frame 28 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3 All New Lots
Hide Arm/Group Description:

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
Overall Number of Participants Analyzed 146 195 192 194 581
Measure Type: Count of Participants
Unit of Measure: Participants
Seroprotection
126
  86.3%
160
  82.1%
154
  80.2%
164
  84.5%
478
  82.3%
No seroprotection
20
  13.7%
35
  17.9%
38
  19.8%
30
  15.5%
103
  17.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection New Lot #1, New Lot #2
Comments

Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.

Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%.

Type of Statistical Test Equivalence
Comments The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.84
Confidence Interval (2-Sided) 95%
-5.97 to 9.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection New Lot #1, New Lot #3
Comments

Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.

Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%.

Type of Statistical Test Equivalence
Comments The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.48
Confidence Interval (2-Sided) 95%
-9.92 to 4.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection New Lot #2, New Lot #3
Comments

Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.

Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%.

Type of Statistical Test Equivalence
Comments The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.33
Confidence Interval (2-Sided) 95%
-11.94 to 3.31
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Reference Lot, All New Lots
Comments

Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.

Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%.

Type of Statistical Test Non-Inferiority
Comments The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.03
Confidence Interval (2-Sided) 95%
-9.74 to 3.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Titers (GMT)
Hide Description Geometric Mean Titers of Neutralizing anti-JEV antibody
Time Frame 28 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3 All New Lots
Hide Arm/Group Description:

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
Overall Number of Participants Analyzed 146 195 192 194 581
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
77.3
(59.6 to 100.4)
52.8
(42.9 to 65.1)
53.4
(42.4 to 67.2)
62.8
(50.3 to 78.4)
56.2
(49.5 to 63.8)
3.Secondary Outcome
Title Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
Hide Description

Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine:

Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema

Time Frame Within 30 minutes of vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All study subjects receiving vaccine were included in this measure.
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3
Hide Arm/Group Description:

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Overall Number of Participants Analyzed 163 220 211 224
Measure Type: Count of Participants
Unit of Measure: Participants
Any immediate RE
0
   0.0%
6
   2.7%
5
   2.4%
2
   0.9%
No immediate RE
163
 100.0%
214
  97.3%
206
  97.6%
222
  99.1%
4.Secondary Outcome
Title Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
Hide Description Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine
Time Frame Within 7 days of vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccine were assessed for this measure.
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3
Hide Arm/Group Description:

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Overall Number of Participants Analyzed 163 220 211 224
Measure Type: Count of Participants
Unit of Measure: Participants
Any RE
51
  31.3%
75
  34.1%
81
  38.4%
61
  27.2%
No RE
112
  68.7%
145
  65.9%
130
  61.6%
163
  72.8%
5.Secondary Outcome
Title Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
Hide Description Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period.
Time Frame Between 7 and 28 days of vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccine were evaluated for this measure.
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3
Hide Arm/Group Description:

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Overall Number of Participants Analyzed 163 220 211 224
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
60
  36.8%
84
  38.2%
92
  43.6%
77
  34.4%
No AE
103
  63.2%
136
  61.8%
119
  56.4%
147
  65.6%
Time Frame 28 days post-vaccination
Adverse Event Reporting Description Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
 
Arm/Group Title Reference Lot New Lot #1 New Lot #2 New Lot #3
Hide Arm/Group Description

Lot of Vaccine produced in existing facility

Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

First lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Second lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Third lot of vaccine produced in new facility

Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

All-Cause Mortality
Reference Lot New Lot #1 New Lot #2 New Lot #3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/220 (0.00%)   0/211 (0.00%)   0/224 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Reference Lot New Lot #1 New Lot #2 New Lot #3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/163 (1.23%)   4/220 (1.82%)   4/211 (1.90%)   0/224 (0.00%) 
Gastrointestinal disorders         
Dysentery  1  1/163 (0.61%)  0/220 (0.00%)  0/211 (0.00%)  0/224 (0.00%) 
Diarrhea  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Acute watery diarrhea  1  0/163 (0.00%)  0/220 (0.00%)  3/211 (1.42%)  0/224 (0.00%) 
Acute gastroenteritis  1  0/163 (0.00%)  0/220 (0.00%)  1/211 (0.47%)  0/224 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Severe pneumonia  1  1/163 (0.61%)  3/220 (1.36%)  0/211 (0.00%)  0/224 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reference Lot New Lot #1 New Lot #2 New Lot #3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/163 (36.81%)   84/220 (38.18%)   92/211 (43.60%)   77/224 (34.38%) 
Gastrointestinal disorders         
Aphthous stomatitis  1  0/163 (0.00%)  1/220 (0.45%)  1/211 (0.47%)  0/224 (0.00%) 
Diarrhea  1  13/163 (7.98%)  15/220 (6.82%)  21/211 (9.95%)  8/224 (3.57%) 
Gastroenteritis  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Mucous stools  1  0/163 (0.00%)  0/220 (0.00%)  0/211 (0.00%)  1/224 (0.45%) 
Vomiting  1  8/163 (4.91%)  15/220 (6.82%)  17/211 (8.06%)  9/224 (4.02%) 
Injection site erythema  1  1/163 (0.61%)  1/220 (0.45%)  1/211 (0.47%)  0/224 (0.00%) 
Injection site pain  1  5/163 (3.07%)  4/220 (1.82%)  3/211 (1.42%)  5/224 (2.23%) 
General disorders         
Injection site inflammation  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Injection site swelling  1  1/163 (0.61%)  1/220 (0.45%)  2/211 (0.95%)  0/224 (0.00%) 
Irritability  1  7/163 (4.29%)  9/220 (4.09%)  8/211 (3.79%)  6/224 (2.68%) 
Pain  1  1/163 (0.61%)  1/220 (0.45%)  4/211 (1.90%)  5/224 (2.23%) 
Pyrexia  1  40/163 (24.54%)  56/220 (25.45%)  61/211 (28.91%)  53/224 (23.66%) 
Swelling  1  0/163 (0.00%)  0/220 (0.00%)  2/211 (0.95%)  1/224 (0.45%) 
Tenderness  1  7/163 (4.29%)  5/220 (2.27%)  6/211 (2.84%)  10/224 (4.46%) 
Infections and infestations         
Abscess  1  0/163 (0.00%)  0/220 (0.00%)  0/211 (0.00%)  1/224 (0.45%) 
Acarodermatitis  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Furuncle  1  1/163 (0.61%)  1/220 (0.45%)  1/211 (0.47%)  1/224 (0.45%) 
Nasopharyngitis  1  3/163 (1.84%)  8/220 (3.64%)  3/211 (1.42%)  4/224 (1.79%) 
Oral candidiasis  1  0/163 (0.00%)  0/220 (0.00%)  0/211 (0.00%)  1/224 (0.45%) 
Metabolism and nutrition disorders         
Decreased appetite  1  36/163 (22.09%)  27/220 (12.27%)  31/211 (14.69%)  31/224 (13.84%) 
Dehydration  1  0/163 (0.00%)  0/220 (0.00%)  1/211 (0.47%)  0/224 (0.00%) 
Nervous system disorders         
Crying  1  13/163 (7.98%)  11/220 (5.00%)  12/211 (5.69%)  11/224 (4.91%) 
Somnolence  1  1/163 (0.61%)  4/220 (1.82%)  1/211 (0.47%)  2/224 (0.89%) 
Psychiatric disorders         
Insomnia  1  9/163 (5.52%)  6/220 (2.73%)  11/211 (5.21%)  5/224 (2.23%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Cough  1  5/163 (3.07%)  18/220 (8.18%)  19/211 (9.00%)  14/224 (6.25%) 
Dyspnea  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Nasopharyngitis  1  3/163 (1.84%)  8/220 (3.64%)  3/211 (1.42%)  4/224 (1.79%) 
Rhinorhhea  1  2/163 (1.23%)  5/220 (2.27%)  5/211 (2.37%)  5/224 (2.23%) 
Skin and subcutaneous tissue disorders         
Erythema  1  0/163 (0.00%)  0/220 (0.00%)  2/211 (0.95%)  0/224 (0.00%) 
Furuncle  1  1/163 (0.61%)  1/220 (0.45%)  1/211 (0.47%)  1/224 (0.45%) 
Pruritus  1  0/163 (0.00%)  1/220 (0.45%)  0/211 (0.00%)  0/224 (0.00%) 
Pruritis generalized  1  0/163 (0.00%)  0/220 (0.00%)  0/211 (0.00%)  1/224 (0.45%) 
Rash  1  1/163 (0.61%)  0/220 (0.00%)  0/211 (0.00%)  0/224 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Lower than anticipated rates of enrollment across all groups made it necessary to analyze antibody response data in smaller samples than initially planned. This adversely influenced the precision of all estimates (i.e., resulted in broader 95% CIs)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jorge Flores
Organization: PATH
Phone: (202) 822-0033
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01567865     History of Changes
Other Study ID Numbers: JEV05 (VAC004)
First Submitted: March 28, 2012
First Posted: March 30, 2012
Results First Submitted: April 13, 2018
Results First Posted: November 12, 2018
Last Update Posted: December 5, 2018