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

Poliomyelitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475539
• Other study ID #: IPV30
• Secondary ID: U1111-1122-1928
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2011
• Last updated: January 9, 2015
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 2 Months

Eligibility

Inclusion Criteria:

• Aged =2 months and less than 3 months on the day of first study vaccine administration

• Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg

• Informed consent form has been signed and dated by the parent or other legally acceptable representative

• Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

• Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except Diphtheria, Tetanus, acellular Pertussis vaccine [DTaP], Haemophilus Influenzae Type b [Hib] vaccine, bacille Calmette-Guerin vaccine [BCG] and Hepatitis B given at least 7 days before and after study vaccination)Previous vaccination against poliomyelitis with either the trial vaccine or another vaccine

• Receipt of immune globulins, blood or blood-derived products since birth

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)

• Congenital or acquired immunodeficiency in close contacts to the subjects

• History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)

• At high risk for human immunodeficiency virus (HIV) infection during the trial

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances

• Laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature =37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

• Any other contraindication as listed in the study vaccines' leaflets.

Study Design

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

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

Biological:
• Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
0.5 mL, Intramuscular + 1g dragee candy oral dose
• Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
0.5 mL, Intramuscular + 1g dragee candy oral dose
• Live oral poliovirus type 1, 2 and 3
1g dragee candy, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Antibodies to the vaccine antigens will be determined by a microneutralization assay.	1 month post-dose 3 (primary vaccination series)	No
Secondary	Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine.	Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.	Day 0 up to 17 months post-vaccination	No
Secondary	Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers		Day 0 and up to 16 months post-vaccination	No

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