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OpenTrials
Completed

NCT Number: NCT00348387

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

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.

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Key information

Age range

60 day–70 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guilin, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poliomyelitis Vaccine inactivated

Biological

0.5 mL, Intramuscular

Other names: IMOVAX Polio ™

Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)

Biological

1g dragee, oral

Other names: Poliomyelitis Vaccine in Dragee Candy

Primary outcomes

  1. To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine

    Time frame: 1 month post-vaccination 3

Secondary outcomes

  1. To provide information concerning the safety of IMOVAX Polio™ vaccine

    Time frame: Entire study period

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2006
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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