Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months (VIPV-06)

November 12, 2018 updated by: Statens Serum Institut

Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 6, 10, 14 Weeks and 9 Months of Age

The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)

Study Overview

Status

Completed

Conditions

Detailed Description

In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:

Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.

2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.

Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood sample is taken for polio antibody measurements, contraindications are reviewed, the 4th vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded. The end of trial form is completed.

Study Type

Interventional

Enrollment (Actual)

1002

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Manila, Philippines
        • 5 sites in Philippines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
  2. Healthy assessed from medical history and physical examination
  3. Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
  4. Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
  5. Parent(s)/guardian(s) granting access to the infant's trial related medical records
  6. Parent(s)/guardian(s) likely to comply with the trial procedures

Exclusion Criteria:

  1. Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
  2. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial
  3. Low birth weight (< 2,500 g)
  4. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
  5. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
  6. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
  7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
  8. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial
  9. Participating in another clinical trial
  10. Not suitable for inclusion in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
ACTIVE_COMPARATOR: IPV SSI
IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
Other Names:
  • IPV Vaccine SSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI
Time Frame: Change from baseline to one month after 3rd vaccination
Change from baseline to one month after 3rd vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event following vaccinations (key secondary)
Time Frame: After primary injections at 2, 4 and 6 months of age
After primary injections at 2, 4 and 6 months of age
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: Before and one month after the 4th vaccination
Before and one month after the 4th vaccination
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Time Frame: Before and one month after the 4th vaccination
Before and one month after the 4th vaccination
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination
From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination

Other Outcome Measures

Outcome Measure
Time Frame
Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres
Time Frame: From baseline to one month after 3rd vaccination
From baseline to one month after 3rd vaccination
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3
Time Frame: One month after 3rd vaccinations
One month after 3rd vaccinations
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3
Time Frame: Before and one month after 4th vaccination
Before and one month after 4th vaccination
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - post-vaccination titre ≥ 4-fold above maternal titre against poliovirus types 1, 2 and 3
Time Frame: One month after 3th vaccination
One month after 3th vaccination
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3
Time Frame: One month after 3th vaccination
One month after 3th vaccination
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3
Time Frame: Before and one month after 4th vaccination
Before and one month after 4th vaccination
Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline to one month after 4th vaccination
From baseline to one month after 4th vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2017

Primary Completion (ACTUAL)

September 21, 2017

Study Completion (ACTUAL)

March 12, 2018

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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