Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age (VIPV-07)

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 2, 4 and 6 Months of Age

The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.

Study Overview

Status

Completed

Conditions

Detailed Description

In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines are administered in the opposite (LEFT) thigh.

At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, demographics and concomitant medication are collected and a physical examination is performed and vital signs are measured. A prevaccination blood sample is taken for polio antibody determinations and the subject is randomly allocated into one of the two vaccination groups and vaccinated. A subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3. The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary, thermometer and ruler are handed out to the parents for measurements of temperature and recording of injection site reactions and solicited systemic AEs. These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved, and for recording of any other AEs as instructed by the trial staff. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.

At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is administered, immediate reactions are observed and the eDiary is returned to the partents for recordings of AEs and concomitant medications. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.

At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and concomitant medication are recorded. A blood sample from a subset of the subjects is taken for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is given, immediate reactions are observed and the eDiary is returned to the parents. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.

At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is collected and AEs and concomitant medications are recorded and a blood sample for polio antibody determination is taken.

A safety follow-up telephone call will be conducted at 12 months of age.

Study Type

Interventional

Enrollment (Actual)

800

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

      • Panama City, Panama, 0816-00383
        • CEVAXIN

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 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants 2 months of age (54-75 days of age) on date of first vaccination
  • Healthy assessed from medical history and physical examination
  • Parent(s)/guardian(s) have been properly informed about the trial and signed informed consent form
  • Parent(s)/guardian(s)granted access to the infant's trial related medical records
  • Parent(s)/guardian(s)are likely to comply with trial procedures

Exclusion Criteria:

  • Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
  • 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
  • Low birth weight (< 2,500 g)
  • Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
  • Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
  • Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
  • Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
  • Treatment with a product which is likely to modify the immune response (e.g. systemic corticosteroids, blood products and immunoglobulins) prior to inclusion or planned during the trial period
  • Participating in another clinical trial
  • 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 Assignment
  • 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 of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age
Active Comparator: IPV SSI
IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
Total of three primary injections of IPV SSI, one at 2, 4 and 6 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 in infants
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
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Adverse events 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 poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
One months after 3rd vaccination
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline and one months after 3rd vaccination
From baseline and one months after 3rd vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject with seroconversion against poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
Two months after 2nd vaccination
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
Two months after 2nd vaccination
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody
Time Frame: Two months after 2nd vaccination
Two months after 2nd vaccination
Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
Two months after 2nd vaccination
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline and two months after 2nd vaccination
From baseline and two months after 2nd vaccination
Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres
Time Frame: From baseline and one months after 3rd vaccination
From baseline and one months after 3rd vaccination
Sensitivity analysis: sub-groups of subjects with seroprotection (titre ≥ 8) and without seroprotection (titre < 8) at baseline
Time Frame: One months after 3rd vaccination
  • Subjects with seroconversion against poliovirus types 1, 2 and 3
  • Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3
  • Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody
  • Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
  • Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 at baseline and one month after 3rd vaccination.
One months after 3rd 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)

January 19, 2017

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 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)?

NO

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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