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

January 9, 2015 updated by: Sanofi Pasteur, a Sanofi Company

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.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangxi
      • Nanning, Guangxi, China, 530028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
0.5 mL, Intramuscular + 1g dragee candy oral dose
Other Names:
  • IMOVAX 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)
0.5 mL, Intramuscular + 1g dragee candy oral dose
Other Names:
  • IMOVAX Polio®
Experimental: Group C (Reference): OPV-OPV-OPV
Participants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV)
1g dragee candy, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 month post-dose 3 (primary vaccination series)
Antibodies to the vaccine antigens will be determined by a microneutralization assay.
1 month post-dose 3 (primary vaccination series)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine.
Time Frame: 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.
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
Day 0 and up to 16 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Sanofi Pasteur China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (Estimate)

November 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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