CClinicalTrials.gg
CompletedNCT00885157Updated Jan 22, 2014

Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly

A Phase 2 interventional study of Inactivated types 1, 2, and 3 poliovirus, D antigens and Inactivated types 1, 2, and 3 poliovirus, D antigens in Poliomyelitis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Philippines. Open to participants aged 15 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
225
Allocation
Non-randomized
Ages
15 Months to 18 Months
Sex
All
01

Study summary

The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety.

Objectives:

  • To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study.
  • To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.
02

Conditions studied

  • Poliomyelitis

Browse trials for

Keywords

  • Poliomyelitis
  • intradermal
03

In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 225 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 15 to 18 months on the day of inclusion
  • 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
  • Child having completed all visits of the IPV25 study (NCT00604058), including the three-dose primary vaccination series with the study vaccine (IMOVAX Polio), using the route of administration as designated by randomization.

Exclusion criteria

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or 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 of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine during the present trial period
  • Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
  • History of seizures
  • History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Previous fourth dose 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 IM injection
  • Febrile illness (temperature ≥38.0 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (actual)

Study arms

  • Experimental
    Group A

    Will receive fractional doses of IPV Intradermally

    Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens

  • Active comparator
    Group B

    Will receive full doses of IPV Intramuscularly

    Biological: Inactivated types 1, 2, and 3 poliovirus, D antigens

Interventions

  • BiologicalInactivated types 1, 2, and 3 poliovirus, D antigens

    0.1 mL, intradermal

    Also known as: Imovax Polio

  • BiologicalInactivated types 1, 2, and 3 poliovirus, D antigens

    0.5 mL, Intramuscular

    Also known as: Imovax Polio

06

What researchers measure

Primary outcomes

  1. Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination.

    Time frame: 30 days post-vaccination

  2. Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine

    Time frame: 30 days post-vaccination and entire study duration

07

Study locations

1 site
  • Quezon city, Manila, Philippines
08

References and documents

Publications

  • Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis. 2012 Feb;16(2):e110-6. doi: 10.1016/j.ijid.2011.10.002. Epub 2011 Dec 5. PubMed 22153001 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00885157
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Apr 21, 2009
Start date
Apr 2009
Primary completion
Oct 2009
Completion
Dec 2009
Last update
Jan 22, 2014

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion