Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
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|ClinicalTrials.gov Identifier: NCT02005536|
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
- To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster
- To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
- To investigate the safety after dosing of SP059 as 2nd booster.
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis Polio||Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine||Phase 4|
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Study Group
Participants will receive one booster dose of SP059 (IMOVAX POLIO®)
Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
- Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® [ Time Frame: Day 28 post-vaccination ]A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
- Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination ]Anti-polio virus antibodies were assessed by virus neutralization assay.
- Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination ]Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay
- Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 28 post-booster vaccination ]Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.
- Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 up to Day 7 post-vaccination ]Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for 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): NCT02005536
|Study Director:||Medical Director||Sanofi K.K.|