Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

January 20, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 2

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

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

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion Criteria to be checked at the screening visit (SC):
  • Aged 0 to 7 days on the day of screening
  • Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
  • Informed consent form signed by the parent(s) or other legally acceptable representative
  • Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Inclusion Criteria to be checked at the randomization visit (V01):
  • Aged 42 to 50 days on the day of inclusion
  • Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures

Exclusion Criteria:

  • Exclusion Criteria to be checked at the screening visit (SC):
  • Planned participation in another clinical trial during the present trial period
  • Illness that could interfere with trial conduct or completion, in the opinion of the investigator
  • Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
  • History of seizures
  • Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
  • Thrombocytopenia or bleeding disorder contraindicating IM injection
  • Exclusion Criteria to be checked at the randomization visit (V01):
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
  • Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
  • History of seizures
  • Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
  • History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
  • Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

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
Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
Fractional dose (1/5th) 0.1 mL, intradermally
Other Names:
  • IMOVAX Polio (IPV) vaccine
Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
A full dose, 0.5 mL, intramuscular
Other Names:
  • IMOVAX Polio (IPV) vaccine
Active Comparator: Group B
Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
Fractional dose (1/5th) 0.1 mL, intradermally
Other Names:
  • IMOVAX Polio (IPV) vaccine
Biological: Inactivated Poliomyelitis vaccine (IMOVAX)
A full dose, 0.5 mL, intramuscular
Other Names:
  • IMOVAX Polio (IPV) vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
Time Frame: 1 Month Post-vaccination
1 Month Post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines
Time Frame: 1 Month post-vaccination
1 Month post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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.

General Publications

Helpful Links

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

January 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPV25

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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