Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
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|ClinicalTrials.gov Identifier: NCT01784874|
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 9, 2018
The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA.
- To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42.
- To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.
- To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule.
- To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series.
- To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.
|Condition or disease||Intervention/treatment||Phase|
|Rabies||Biological: Purified Vero Rabies Vaccine (VRVg) - Serum Free Biological: Imovax® Rabies: inactivated rabies vaccine||Phase 2|
The vaccination will be given in three injections, at Day 0, Day 7, and Day 28, respectively, based on the Advisory Committee on Immunization Practice (ACIP) and the World Health Organization (WHO) recommendations for pre-exposure regimen. A booster dose will be administered 1 year after the first vaccine injection in a randomized subset of participants.
Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to Month 12.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in Pre-exposure Use in Healthy Adults|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||December 2015|
Experimental: Purified Vero Rabies Vaccine Group
Participants will receive the Purified Vero Rabies Vaccine (VRVg) Serum Free
Biological: Purified Vero Rabies Vaccine (VRVg) - Serum Free
0.5 mL, Intramuscular
Experimental: Imovax® Rabies Vaccine Group
Participants will receive the Imovax® Rabies
Biological: Imovax® Rabies: inactivated rabies vaccine
1.0 mL, Intramuscular
Other Name: Imovax® Rabies
- Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series). [ Time Frame: Day 42 post-vaccination ]Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
- Antibody Persistence in terms of rabies virus neutralizing antibody titers at 6 months and 12 months after the first vaccination [ Time Frame: 6 and 12 months post-vaccination ]Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
- Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 up to 12 months post-vaccination ]Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784874
|United States, California|
|Redding, California, United States, 96001|
|Sacramento, California, United States, 95815|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68134|
|United States, Texas|
|Austin, Texas, United States, 78705|
|Fort Worth, Texas, United States, 76135|
|United States, Utah|
|Salt Lake City, Utah, United States, 84124|
|Study Director:||Medical Director||Sanofi Pasteur SA|