Polio, Poliomyelitis
Conditions
Keywords
Poliomyelitis, Poliovirus, Polio, IMOVAX POLIO®, Inactivated polio vaccine
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 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.
Interventions
BIOLOGICALIMOVAX POLIO®: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | 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® | 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® | 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® | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan.
Pre-assignment details
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.
Participants by arm
| Arm | Count |
|---|---|
| IMOVAX POLIO® Vaccine Group Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | IMOVAX POLIO® Vaccine Group |
|---|---|
| Age, Categorical <=18 years | 60 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.0 years STANDARD_DEVIATION 0.2 |
| Region of Enrollment Japan | 60 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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.
Time frame: Day 28 post-vaccination
Population: Anti-polio booster response was assessed in the per-protocol analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | Anti-polio 1 | 78.0 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | Anti-polio 2 | 78.0 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® | Anti-polio 3 | 79.7 Percentage of participants |
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.
Time frame: Day 28 post-booster vaccination
Population: Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IMOVAX POLIO® Vaccine Group | Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio 1 | 12.1 Titer Ratio |
| IMOVAX POLIO® Vaccine Group | Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio 2 | 11.6 Titer Ratio |
| IMOVAX POLIO® Vaccine Group | Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® | Anti-polio 3 | 16.7 Titer Ratio |
Secondary
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio virus antibodies were assessed by virus neutralization assay.
Time frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Population: Geometric mean titers was assessed in the per-protocol analysis set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio 1 (pre-vaccination) | 312.6 Titers |
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio 1 (post-vaccination) | 3794.9 Titers |
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio 2 (pre-vaccination) | 795.4 Titers |
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Ant-polio 2 (post-vaccination) | 9213.2 Titers |
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio 3 (pre-vaccination) | 314.5 Titers |
| IMOVAX POLIO® Vaccine Group | Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® | Anti-polio 3 (post-vaccination) | 5242.1 Titers |
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.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Injection-site Pain | 13 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Injection-site Pain | 0 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Injection-site Erythema | 41 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Injection-site Erythema | 1 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Injection-site Swelling | 21 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Injection-site Swelling | 0 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Fever | 8 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Fever | 2 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Headache | 4 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Headache | 0 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Malaise | 18 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Malaise | 0 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Any Myalgia | 1 Number of participants |
| IMOVAX POLIO® Vaccine Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | Grade 3 Myalgia | 0 Number of participants |
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
Time frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Population: Anti-polio booster response was assessed in the per-protocol analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti-polio 1 (pre-vaccination) | 100 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti-polio 1 (post-vaccination) | 100 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti -polio 2 (pre-vaccination) | 100 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti-polio 2 (post-vaccination) | 100 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti-polio 3 (pre-vaccination) | 98.3 Percentage of participants |
| IMOVAX POLIO® Vaccine Group | Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | Anti-polio 3 (post-vaccination) | 100 Percentage of participants |