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

Poliomyelitis Clinical Trial

Official title:

Immunogenicity and Safety of Fractional Booster Dose of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally Versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885157
• Other study ID #: IPV26
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2009
• Last updated: January 20, 2014
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Months to 18 Months

Eligibility

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:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated types 1, 2, and 3 poliovirus, D antigens
0.1 mL, intradermal
• Inactivated types 1, 2, and 3 poliovirus, D antigens
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination.		30 days post-vaccination	No
Primary	Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine		30 days post-vaccination and entire study duration	Yes

External Links

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