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

NCT00604058 | Completed Phase 2 DMC

• 1 other identifier: IPV25
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poliomyelitis

Keywords

Poliomyelitis; intradermal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Biological: Inactivated Poliomyelitis vaccine (IMOVAX)

Group B

ACTIVE COMPARATOR

Biological: Inactivated Poliomyelitis vaccine (IMOVAX)

Interventions

Inactivated Poliomyelitis vaccine (IMOVAX) BIOLOGICAL

Fractional dose (1/5th) 0.1 mL, intradermally

Also known as: IMOVAX Polio (IPV) vaccine

Group A

Eligibility Criteria

• Age: 42 Days - 50 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Quezon City, Manila, Philippines

Location

Related Publications (1)

• 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.

  PMID: 22153001 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated; Rabies Vaccines; Vaccines

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

PH (1)