NCT01475539

Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

Immunogenicity and Safety of Different Sequential Schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) Followed by Oral Poliomyelitis Vaccine in Healthy Infants in China Versus Oral Poliomyelitis Vaccine Alone.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 2 Months
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Polio
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio	0.5 mL, Intramuscular + 1g dragee candy oral dose
BIOLOGICAL	Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio	0.5 mL, Intramuscular + 1g dragee candy oral dose
BIOLOGICAL	Live oral poliovirus type 1, 2 and 3	1g dragee candy, oral

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-05-01
• Completion: 2013-11-01
• First posted: 2011-11-21
• Last updated: 2015-01-12

Locations

1 site across 1 country: China