AzTrials
AzTrials

PolioPhase 4NCT01475539

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

A Phase 4 study testing Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio and Live oral poliovirus type 1, 2 and 3 in people with Polio and Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 2 to 2 monthsHealthy volunteers can take part
Conditions the study is for
Polio, Poliomyelitis
What is being tested?
Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio and Live oral poliovirus type 1, 2 and 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
1 siteChina
Study dates
Nov 2011to Nov 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 2 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Study site

    Nanning, Guangxi, 530028

Other trials in China

About this study

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.

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:

Read more
  • 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.
Read the 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
Being tested
Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio, Live oral poliovirus type 1, 2 and 3
Keywords
Polio, Poliovirus, Oral poliovirus vaccine, IMOVAX Polio®
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injectable inactivated types 1, 2 and 3 poliovirus + Live oral PolioBiological

    Also called IMOVAX Polio®

    0.5 mL, Intramuscular + 1g dragee candy oral dose

  • Injectable inactivated types 1, 2 and 3 poliovirus + Live oral PolioBiological

    Also called IMOVAX Polio®

    0.5 mL, Intramuscular + 1g dragee candy oral dose

  • Live oral poliovirus type 1, 2 and 3Biological

    1g dragee candy, oral

Study groups in NCT01475539
Study groupRoleWhat they receive
Group A (Sequential 1): IPV-OPV-OPVExperimentalParticipants will receive 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 2 doses of a commercially available Oral Poliovirus Vaccine (OPV)
Receives: Biological: Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
Group B (Sequential 2): IPV-IPV-OPVExperimentalParticipants will receive 2 doses of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 1 dose of a commercially available Oral Poliovirus Vaccine (OPV)
Receives: Biological: Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio
Group C (Reference): OPV-OPV-OPVExperimentalParticipants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV)
Receives: Biological: Live oral poliovirus type 1, 2 and 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month post-dose 3 (primary vaccination series)

Secondary outcomes (2)

  1. 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.

    Measured: Day 0 up to 17 months post-vaccination

  2. Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers

    Measured: Day 0 and up to 16 months post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01475539
Sponsor's protocol ID
IPV30
Other IDs
U1111-1122-1928
Status last verified
Jan 2015
First submitted
14 Nov 2011
Last updated
12 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Li RC, Li CG, Wang HB, Luo HM, Li YP, Wang JF, Ying ZF, Yu WZ, Shu JD, Wen N, Vidor E. 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. J Pediatric Infect Dis Soc. 2016 Sep;5(3):287-96. doi: 10.1093/jpids/piv017. Epub 2015 Apr 16.

    PubMed 26407255

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio and Live oral poliovirus type 1, 2 and 3 in people with Polio and Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01475539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in