CompletedNCT01475539Updated Jan 12, 2015

Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

A Phase 4 interventional study of Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio and Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio in Polio and Poliomyelitis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in China. Open to participants aged 2 Months to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-12.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 456
Allocation: Randomized
Ages: 2 Months to 2 Months
Sex: All

Study 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.

Read the 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.

Conditions studied

Polio
Poliomyelitis

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Poliomyelitis 222

Keywords

Polio
Poliovirus
Oral poliovirus vaccine
IMOVAX Polio®

In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 456 is close to the median of 456 across 199 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 2 Months
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 456 participants (actual)

Study arms

Experimental
Group A (Sequential 1): IPV-OPV-OPV
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)
Biological: Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
Experimental
Group B (Sequential 2): IPV-IPV-OPV
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)
Biological: Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
Experimental
Group C (Reference): OPV-OPV-OPV
Participants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV)
Biological: Live oral poliovirus type 1, 2 and 3

Interventions

BiologicalInjectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
0.5 mL, Intramuscular + 1g dragee candy oral dose
Also known as: IMOVAX Polio®
BiologicalInjectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
0.5 mL, Intramuscular + 1g dragee candy oral dose
Also known as: IMOVAX Polio®
BiologicalLive oral poliovirus type 1, 2 and 3
1g dragee candy, oral

What researchers measure

Primary outcomes

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.
Time frame: 1 month post-dose 3 (primary vaccination series)

Secondary outcomes

Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine.
Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Time frame: Day 0 up to 17 months post-vaccination
Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers
Time frame: Day 0 and up to 16 months post-vaccination

Study locations

1 site

Nanning, Guangxi 530028, China

References and documents

Publications

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. PubMed 26407255 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01475539
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Nov 21, 2011
Start date: Nov 2011
Primary completion: May 2013
Completion: Nov 2013
Last update: Jan 12, 2015

Study contacts

Medical Director

study director · Sanofi Pasteur China

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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