Polio, Poliomyelitis
Conditions
Keywords
Polio, Poliovirus, Oral poliovirus vaccine, IMOVAX Polio®
Brief summary
The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination. Primary objective: * To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series. Secondary objectives: * To evaluate the safety profile of the investigational vaccines after each administration in each group. * To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group. * To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.
Detailed description
Study participants will be randomized to receive either 3 doses of a commercially available Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine IMOVAX Polio (IPV) followed by 2 doses of OPV, or 2 doses of IPV followed by 1 dose of OPV. These vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for the prevention of poliomyelitis. Participants will be followed up through their 18th- to 19th-month birthday.
Interventions
BIOLOGICALInjectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
0.5 mL, Intramuscular + 1g dragee candy oral dose
BIOLOGICALLive oral poliovirus type 1, 2 and 3
1g dragee candy, oral
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥2 months and less than 3 months on the day of first study vaccine administration * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Informed consent form has been signed and dated by the parent or other legally acceptable representative * Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except Diphtheria, Tetanus, acellular Pertussis vaccine \[DTaP\], Haemophilus Influenzae Type b \[Hib\] vaccine, bacille Calmette-Guerin vaccine \[BCG\] and Hepatitis B given at least 7 days before and after study vaccination)Previous vaccination against poliomyelitis with either the trial vaccine or another vaccine * Receipt of immune globulins, blood or blood-derived products since birth * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) * Congenital or acquired immunodeficiency in close contacts to the subjects * History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) * At high risk for human immunodeficiency virus (HIV) infection during the trial * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * Any other contraindication as listed in the study vaccines' leaflets.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. | 1 month post-dose 3 (primary vaccination series) | Antibodies to the vaccine antigens will be determined by a microneutralization assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine. | Day 0 up to 17 months post-vaccination | Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability. |
| Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers | Day 0 and up to 16 months post-vaccination | — |
Countries
China
Outcome results
None listed