Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV - Full Text View

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 III

MedlinePlus related topics:

Polio and Post-Polio Syndrome

ChemIDplus related topics:

Poliovirus Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Poliomyelitis Vaccine inactivated 0.5 mL, Intramuscular
2: Active Comparator	Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) 1g dragee, oral

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 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

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

Locations


China, Guangxi Province

	PingLe county, Guangxi Province, China, 542400

	Guilin City,, Guangxi Province, China, 541001

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Medical Director	Sanofi Pasteur Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur ( Medical Director )
Study ID Numbers:	IPV13
First Received:	July 3, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00348387
Health Authority:	China: State Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Imovax polio

poliomyelitis

Study placed in the following topic categories:

Virus Diseases

Neuromuscular Diseases

Spinal Cord Diseases

Central Nervous System Infections

Poliomyelitis

Central Nervous System Diseases

Picornaviridae Infections

Myelitis

Degenerative motor system disease

Enterovirus Infections

Motor neuron disease

Motor Neuron Disease

Additional relevant MeSH terms:

RNA Virus Infections

Nervous System Diseases

Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00348387