Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

Poliomyelitis Clinical Trial

Official title:

Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005536
• Other study ID #: IPV46 (EFC13614)
• Secondary ID: U1111-1143-8561
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2013
• Last updated: March 27, 2015
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

Biological:
• IMOVAX POLIO®: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®	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.	Day 28 post-vaccination	No
Secondary	Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®	Anti-polio virus antibodies were assessed by virus neutralization assay.	Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination	No
Secondary	Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®	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	Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination	No
Secondary	Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®	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.	Day 28 post-booster vaccination	No
Secondary	Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®	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.	Day 0 up to Day 7 post-vaccination	No

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