Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine
Immunogenicity and Safety of Different Sequential Schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) Followed by Oral Poliomyelitis Vaccine in Healthy Infants in China Versus Oral Poliomyelitis Vaccine Alone.
2 other identifiers
interventional
456
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 12, 2015
January 1, 2015
1.5 years
November 14, 2011
January 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Antibodies to the vaccine antigens will be determined by a microneutralization assay.
1 month post-dose 3 (primary vaccination series)
Secondary Outcomes (2)
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
Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers
Day 0 and up to 16 months post-vaccination
Study Arms (3)
Group A (Sequential 1): IPV-OPV-OPV
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV)
Interventions
0.5 mL, Intramuscular + 1g dragee candy oral dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Nanning, Guangxi, 530028, China
Related Publications (1)
Li RC, Li CG, Wang HB, Luo HM, Li YP, Wang JF, Ying ZF, Yu WZ, Shu JD, Wen N, Vidor E. Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine Versus Oral Polio Vaccine Alone in Healthy Infants in China. J Pediatric Infect Dis Soc. 2016 Sep;5(3):287-96. doi: 10.1093/jpids/piv017. Epub 2015 Apr 16.
PMID: 26407255DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 21, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2013
Study Completion
November 1, 2013
Last Updated
January 12, 2015
Record last verified: 2015-01