CompletedNCT01092507Updated Dec 25, 2013Results posted

A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

A Phase 3 interventional study of Japanese encephalitis chimeric virus vaccine (JE-CV) and Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®) in Encephalitis and Japanese Encephalitis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in Thailand. Open to participants aged 9 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-25.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 300
Allocation: Randomized
Ages: 9 Months to 18 Months
Sex: All

Study summary

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers.

Primary Objective:

To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0).

Secondary Objectives:

To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine
To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination.
To describe only related SAEs and all death from 6 month to 12-month follow-up.

Read the detailed description

All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.

Conditions studied

Encephalitis
Japanese Encephalitis

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Keywords

Encephalitis
Japanese Encephalitis
Japanese Encephalitis Vaccines
Infant

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

This study's enrollment of 300 is close to the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.

Browse Encephalitis, Japanese studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Months to 18 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Aged 9 to 18 months on the day of inclusion
In good general health, without significant medical history
Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations
Subject and parent/legally acceptable representatives able to attend all scheduled visits and comply with all trial procedures
Completion of vaccinations according to the national immunization schedule.

Exclusion criteria

Exclusion Criteria :

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of the immune response
Previous vaccination against flavivirus disease, including Japanese encephalitis (JE)
Administration of any anti-viral within 2 months preceding first vaccination and up to the 4 weeks following the last trial vaccination at Month 3
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine from the inclusion up to the 4 weeks following the last trial vaccination
Planned receipt of any Japanese encephalitis vaccine during the course of the study
History of central nervous system disorder or disease, including seizures
History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 300 participants (actual)

Study arms

Experimental
JE-CV Group
Participants will receive one dose of Japanese encephalitis chimeric virus vaccine (JE-CV)
Biological: Japanese encephalitis chimeric virus vaccine (JE-CV)
Active comparator
SA14-14-2 vaccine Group
Participants will receive one dose of Japanese encephalitis live vaccine, SA14-14-2 vaccine. (CD.JEVAX®)
Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)

Interventions

BiologicalJapanese encephalitis chimeric virus vaccine (JE-CV)
0.5 mL, Subcutaneous
BiologicalJapanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
0.5 mL, Subcutaneous

What researchers measure

Primary outcomes

Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.
Time frame: Day 0 through Day 28 after vaccination

Secondary outcomes

Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.
Time frame: Day 28 post-vaccination
Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer \< 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination.
Time frame: Day 28 post-vaccination
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.
Time frame: Day 28 up to 12 months post-vaccination
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time frame: Day 0 (pre-vaccination) and up to 12 months post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)
Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature \> 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable.
Time frame: Day 0 through Day 14 post-vaccination

Results

Posted Dec 2, 2013

Participant flow

Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.

Participant flow — Overall Study
Milestone	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Started	149	150
Completed	147	150
Not completed	2	0
Withdrew: Withdrawal by subject	2	0

Outcome measures

PrimaryNumber of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)

Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.

Time frame:: Day 0 through Day 28 after vaccination
Reported as:: Number · Participants

Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Participants	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)	125	127

SecondaryNumber of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.

Time frame:: Day 28 post-vaccination
Reported as:: Number · Participants

Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Participants	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Day 0, JE-CV PRNT50 (N = 127, 129)	0	0
Day 28, JE-CV PRNT50 (N = 125, 128)	125	127
Day 0, SA14-14-2 PRNT50 (N = 125, 128)	0	0
Day 28, SA14-14-2 PRNT50 (N = 125, 126)	122	123

SecondaryNumber of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer \< 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination.

Time frame:: Day 28 post-vaccination
Reported as:: Number · Participants

Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Participants	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
JE-CV PRNT50 (N = 126, 128)	125	127
SA14-14-2 PRNT50 (N = 124, 125)	121	122

SecondarySummary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Time frame:: Day 0 (pre-vaccination) and Day 28 post-vaccination
Reported as:: Geometric mean · Titers

Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Titers	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Day 0, JE-CV PRNT50 (N = 127, 129)	5.0 (5.0 to 5.0)	5.0 (5.0 to 5.0)
Day 28, JE-CV PRNT50 (N = 126, 128)	491 (378 to 638)	395 (304 to 514)
Day 0, SA14-14-2 PRNT50 (N = 125, 128)	5.00 (5.00 to 5.00)	5.0 (5.0 to 5.0)
Day 28, SA14-14-2 PRNT50 (N = 125, 126)	205 (162 to 259)	190 (152 to 239)

SecondarySummary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)

Time frame:: Day 28 up to 12 months post-vaccination
Reported as:: Number · Participants

Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Participants	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Day 0, JE-CV PRNT50 (N = 149, 150)	6	5
Day 28, JE-CV PRNT50 (N = 146, 148)	145	147
Month 6, JE-CV PRNT50 (N = 145, 145)	137	141
Month 12, JE-CV PRNT50 (N = 143, 146)	126	142
Day 0, SA14-14-2 PRNT50 (N = 147, 149)	0	0
Day 28, SA14-14-2 PRNT50 (N = 145, 146)	141	142
Month 6, SA14-14-2 PRNT50 (N = 145, 145)	122	129
Month 12, SA14-14-2 PRNT50 (N = 142, 144)	109	126

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Time frame:: Day 0 (pre-vaccination) and up to 12 months post-vaccination
Reported as:: Geometric mean · Titers

Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Titers	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Day 0, JE-CV PRNT50 (N = 149, 150)	5.39 (5.05 to 5.74)	5.29 (4.98 to 5.61)
Day 28, JE-CV PRNT50 (N = 146, 148)	507 (395 to 651)	370 (291 to 470)
Month 6, JE-CV PRNT50 (N = 145, 145)	119 (91.7 to 154)	103 (85.6 to 124)
Month 12, JE-CV PRNT50 (N = 143, 146)	97.6 (74.0 to 129)	121 (96.7 to 151)
Day 0, SA14-14-2 PRNT50 (N = 147, 149)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)
Day 28, SA14-14-2 PRNT50 (N = 145, 146)	198 (158 to 247)	171 (138 to 212)
Month 6, SA14-14-2 PRNT50 (N = 145, 145)	52.7 (41.2 to 67.4)	51.4 (41.6 to 63.6)
Month 12, SA14-14-2 PRNT50 (N = 142, 144)	46.5 (35.8 to 60.4)	54.8 (43.9 to 68.4)

SecondaryNumber of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)

Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature \> 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable.

Time frame:: Day 0 through Day 14 post-vaccination
Reported as:: Number · Participants

Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)
Participants	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
Any injection site Tenderness	44	57
Grade 3 injection site Tenderness	0	1
Any injection site Erythema	26	35
Grade 3 injection site Erythema	0	0
Any injection site Swelling	9	12
Grade 3 injection site Swelling	0	0
Any Fever	24	33
Grade 3 Fever	0	1
Any Vomiting	21	40
Grade 3 Vomiting	1	2
Any Crying Abnormal	28	39
Grade 3 Crying Abnormal	1	2
Any Drowsiness	25	38
Grade 3 Drowsiness	0	0
Any Appetite Loss	32	54
Grade 3 Appetite Loss	0	3
Any Irritability	41	58
Grade 3 Irritability	0	5

Adverse events

Collected over Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination.. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Japanese Encephalitis Chimeric Vaccine (JE-CV)	—	14/147 (9.5%)	66/147 (44.9%)
Japanese Encephalitis Live Vaccine (SA14-14-2)	—	18/152 (11.8%)	88/152 (57.9%)

Most frequent serious events

Showing 10 of 17

Most frequent serious events
Event	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
GastroenteritisInfections and infestations	6/147	1/152
Febrile ConvulsionNervous system disorders	0/147	4/152
Gastroenteritis RotavirusInfections and infestations	0/147	3/152
Viral InfectionInfections and infestations	2/147	1/152
BronchitisInfections and infestations	1/147	2/152
Anal AbscessInfections and infestations	1/147	0/152
Dengue FeverInfections and infestations	1/147	1/152
PharyngitisInfections and infestations	1/147	0/152
PneumoniaInfections and infestations	1/147	0/152
Pneumonia Respiratory Syncytial ViralInfections and infestations	1/147	1/152

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)
IrritabilityGeneral disorders	41/146	58/152
Injection Site TendernessGeneral disorders	44/146	57/152
Appetite LossMetabolism and nutrition disorders	32/146	54/152
VomitingGastrointestinal disorders	21/146	40/152
Crying AbnormalGeneral disorders	28/146	39/152
DrowsinessNervous system disorders	25/146	38/152
Injection Site ErythemaGeneral disorders	26/146	35/152
FeverGeneral disorders	24/147	33/152
Upper Respiratory Tract InfectionInfections and infestations	11/147	31/152
NasopharyngitisInfections and infestations	14/147	10/152

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)	Total
<=18 years	149	150	299
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Months)	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)	Total
Mean	13.1 ± 2.11	13.2 ± 1.89	13.2 ± 2.00

Sex: Female, Male
Sex: Female, Male(Participants)	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)	Total
Female	69	75	144
Male	80	75	155

Region of Enrollment
Region of Enrollment(Participants)	Japanese Encephalitis Chimeric Vaccine (JE-CV)	Japanese Encephalitis Live Vaccine (SA14-14-2)	Total
Thailand	149	150	299

Study locations

3 sites

Bangkok, 10330, Thailand
Bangkok, 10700, Thailand
Khon Kaen, 40002, Thailand

References and documents

Publications

Feroldi E, Pancharoen C, Kosalaraksa P, Chokephaibulkit K, Boaz M, Meric C, Hutagalung Y, Bouckenooghe A. Primary immunization of infants and toddlers in Thailand with Japanese encephalitis chimeric virus vaccine in comparison with SA14-14-2: a randomized study of immunogenicity and safety. Pediatr Infect Dis J. 2014 Jun;33(6):643-9. doi: 10.1097/INF.0000000000000276. PubMed 24717964 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01092507
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Mar 25, 2010
Start date: Mar 2010
Primary completion: Sep 2011
Completion: Oct 2011
Results posted: Dec 2, 2013
Last update: Dec 25, 2013

Study contacts

Medical Director

study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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