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

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604058
• Other study ID #: IPV25
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: January 20, 2014
• Start date: January 2008
• Est. completion date: December 2008

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 50 Days

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis vaccine (IMOVAX)
Fractional dose (1/5th) 0.1 mL, intradermally
• Inactivated Poliomyelitis vaccine (IMOVAX)
A full dose, 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	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		1 Month Post-vaccination	No
Secondary	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		1 Month post-vaccination	Yes

External Links

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