Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00348387
First received: July 3, 2006
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

This study is intended to support the registration of IMOVAX Polio in China.

The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.


Condition Intervention Phase
Poliomyelitis
Polio
Biological: Poliomyelitis Vaccine inactivated
Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine [ Time Frame: 1 month post-vaccination 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of IMOVAX Polio™ vaccine [ Time Frame: Entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
Other Name: IMOVAX Polio ™
Active Comparator: Group 2 Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral
Other Name: Poliomyelitis Vaccine in Dragee Candy

  Eligibility

Ages Eligible for Study:   60 Days to 70 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 2 months (60-70 days) on the day of inclusion into the study
  • Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
  • Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
  • Able to attend all planned clinic appointment and obey and follow all study instructions

Exclusion Criteria:

  • Taking part in another clinical trial during the 4 weeks before the first trial vaccination
  • Have plans to take part in another clinical trial d during this trial period
  • Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
  • Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
  • Prolonged or long time illness that could interfere with study or full participation
  • Received blood or blood-derived products since birth
  • Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
  • Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
  • Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
  • History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
  • Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
  • Bleeding disorder or a low platelet which do not allow vaccination into the muscle
  • Had seizures in the past
  • Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348387

Locations
China
Guilin City,, China, 541001
PingLe county, China, 542400
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00348387     History of Changes
Other Study ID Numbers: IPV13
Study First Received: July 3, 2006
Last Updated: January 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Imovax polio
poliomyelitis

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014