Phase 4
N=60
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Poliomyelitis · Polio
Bottom Line
View on ClinicalTrials.gov: NCT02005536 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® — 78.0; 78.0; 79.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IMOVAX POLIO®: Inactive Poliovirus Vaccine (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® |
78.0; 78.0; 79.7 | — |
| SECONDARY Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® |
312.6; 3794.9; 795.4; 9213.2; 314.5; 5242.1 | — |
| SECONDARY Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® |
100; 100; 100; 100; 98.3; 100 | — |
| SECONDARY Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® |
12.1; 11.6; 16.7 | — |
| SECONDARY Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® |
13; 0; 41; 1; 21; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 4 to 6 years inclusive on the day of inclusion
- Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- Any serious disease whether acute or chronic
- Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- History of poliomyelitis infection
- History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- History of anaphylaxis or allergy to any of the study vaccine components
- Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Participation in another clinical trial within 6 months before the trial inclusion
- Planned participation in another clinical trial during the present trial period
- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination
- Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
- Any vaccination with live vaccines within the past 27 days preceding the trial vaccination
- Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- Subject ineligible according to the Investigator's clinical judgment.
Data sourced from ClinicalTrials.gov (NCT02005536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.