Safety of Imovax Polio in Chinese Infants and Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00258843 |
Recruitment Status :
Completed
First Posted : November 28, 2005
Last Update Posted : January 22, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Poliomyelitis | Biological: Inactivated Poliomyelitis vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants. |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | April 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Children at 18 months of age
|
Biological: Inactivated Poliomyelitis vaccine
0.5 mL, intramuscular (IM)
Other Name: IMOVAX Polio™ (IPV) |
Experimental: Group 2
Infants at 2 months of age
|
Biological: Inactivated Poliomyelitis vaccine
0.5 mL, IM
Other Name: IMOVAX Polio ™ (IPV) |

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Ages Eligible for Study: | 2 Months to 18 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Group 1: Aged 18 months (18-20 months) on the day of inclusion
- Group 2: Aged 2 months (56-70 days) on the day of inclusion
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
- Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2)
- Vaccination planned in the 4 weeks following the trial vaccination
- Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures
- Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258843
China | |
Pingle, China |
Study Director: | Clinical Trials | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00258843 |
Other Study ID Numbers: |
IPV17 |
First Posted: | November 28, 2005 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
IMOVAX; poliomyelitis |
Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases |
Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |