Polio, Poliomyelitis
Conditions
Keywords
Poliomyelitis, Inactivated polio vaccine, Polio, Poliovirus
Brief summary
The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: * To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: * To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. * To describe the safety after each dose of IPV.
Detailed description
Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection. The duration of each participant's participation in the trial will be approximately 1 year.
Interventions
BIOLOGICALInactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 68 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion * 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 * 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 * Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine * Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * Participation in another clinical trial preceding the trial inclusion * Planned participation in another clinical trial during the present trial period * 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 first trial vaccination. * Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination. * Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection * Subject ineligible according to the investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination | 1 month post-vaccination 3 | Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination. | Day 0 and 1 month post-vaccination | — |
| Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV | Day 0 up to 12 months post-vaccination | Solicited injection site: Tenderness (3 to 23 months); Pain (2 to 11 years), Redness, and Swelling. Solicited Systemic reaction: 3 to 23 month olds: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability: 2 to 11 year olds: Fever (Temperature), Headache, Malaise, and Myalgia. |
| Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination. | 1 month post-booster vaccination | Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay. |
Countries
Japan
Outcome results
None listed