Clinical Trial: Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety of Different Sequential Schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) Followed by Oral

Brief Summary:

The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination.

Primary objective:

  • To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series.

Secondary objectives:

  • To evaluate the safety profile of the investigational vaccines after each administration in each group.
  • To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group.
  • To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

Detailed Summary:

Study participants will be randomized to receive either 3 doses of a commercially available Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine IMOVAX Polio (IPV) followed by 2 doses of OPV, or 2 doses of IPV followed by 1 dose of OPV.

These vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for the prevention of poliomyelitis. Participants will be followed up through their 18th- to 19th-month birthday.


Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. [ Time Frame: 1 month post-dose 3 (primary vaccination series) ]

Antibodies to the vaccine antigens will be determined by a microneutralization assay.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine. [ Time Frame: Day 0 up to 17 months post-vaccination ]
    Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
  • Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers [ Time Frame: Day 0 and up to 16 months post-vaccination ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: November 14, 2011
Date Started: November 2011
Date Completion:
Last Updated: January 9, 2015
Last Verified: January 2015