Back to results

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

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 2

Locations

Philippines

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Poliomyelitis, intradermal

Eligibility Criteria

15 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Will receive fractional doses of IPV Intradermally

Will receive full doses of IPV Intramuscularly

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00885157

First Posted

April 20, 2009

Last Updated

January 20, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00885157

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

Keywords

Poliomyelitis, intradermal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Will receive fractional doses of IPV Intradermally

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Will receive full doses of IPV Intramuscularly

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

Imovax Polio

Intervention Description

0.1 mL, intradermal

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

Imovax Polio

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

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

Time Frame

30 days post-vaccination

Title

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

Time Frame

30 days post-vaccination and entire study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Quezon city

State/Province

Manila

Country

Philippines

12. IPD Sharing Statement

Citations:

PubMed Identifier

22153001

Citation

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.

Results Reference

derived

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs