Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005536
|Study Director:||Medical Director||Sanofi K.K.|