NCT01475539

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.

Completed Phase 4 Last updated 9 January 2015

What this trial tests

Phase 4 trial testing Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio in Polio in 456 participants. Completed in 1 November 2013.

Timeline

1 November 2011

Primary endpoint
1 May 2013

1 November 2013

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	456
Start date	1 November 2011
Primary completion	1 May 2013
Estimated completion	1 November 2013
Sites	1 location across China

Drugs / interventions tested

• Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio — full drug profile →
• Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio — full drug profile →
• Live oral poliovirus type 1, 2 and 3 — full drug profile →

Conditions studied

• Polio — all drugs for Polio →
• Poliomyelitis — all drugs for Poliomyelitis →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 2 Months to 2 Months, any sex, with Polio or Poliomyelitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sequential inactivated (IPV) and live oral (OPV) poliovirus vaccines for preventing poliomyelitis.
   Ciapponi A, Bardach A, Rey Ares L, Glujovsky D, et al · · 2019 · cited 14× · PMID 31801180 · DOI 10.1002/14651858.cd011260.pub2
2. Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine Versus Oral Polio Vaccine Alone in Healthy Infants in China.
   Li RC, Li CG, Wang HB, Luo HM, et al · · 2016 · cited 10× · PMID 26407255 · DOI 10.1093/jpids/piv017