Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine
- Conditions
- PoliomyelitisPolio
- Interventions
- Biological: Injectable inactivated types 1, 2 and 3 poliovirus + Live oral PolioBiological: Live oral poliovirus type 1, 2 and 3
- Registration Number
- NCT01475539
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Sequential 1): IPV-OPV-OPV Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio Participants will receive 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 2 doses of a commercially available Oral Poliovirus Vaccine (OPV) Group B (Sequential 2): IPV-IPV-OPV Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio Participants will receive 2 doses of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 1 dose of a commercially available Oral Poliovirus Vaccine (OPV) Group C (Reference): OPV-OPV-OPV Live oral poliovirus type 1, 2 and 3 Participants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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