Clinical Trial: Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
Brief Summary:
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.
Primary Objective:
- 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
Secondary Objectives:
- 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.
Detailed Summary:
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.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® [ Time Frame: Day 28 post-vaccination ]
Original Primary Outcome: Percentage of participants with at least a four-fold rise in anti-Polio 1, 2 and 3 antibody titers between the pre-booster and one month after the dose of IPV [ Time Frame: Day 0 (pre-) and 28 post-booster vaccination ]
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
- Description of the safety profile in terms of solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events after a vaccination with IPV [ Time Frame: Day 0 up to Day 28 post-booster vaccination ]Solicited injection site: Pain, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia; Unsolicited Adverse Event (AE) defined as an observed AE that does not fulfill the conditions pre-listed in the case report form. Serious adverse event defined as: Death, Life threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability incapacity,
- Immunogenicity in terms of percentage of participants with anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], Geometric Mean Titers and Geometric Mean Titers Ratio) of inactivated polio vaccine (IPV) after the booster vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ]Anti-Poliovirus types 1, 2, and 3 titers will be measured by neutralization assay.
Information By: Sanofi
Dates:
Date Received: December 3, 2013
Date Started: December 2013
Date Completion:
Last Updated: March 27, 2015
Last Verified: March 2015