Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age

NCT ID: NCT03025750

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-19
• Study Completion Date: 2017-11-14

Brief Summary

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.

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.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IPV-Al SSI

Intervention Type: BIOLOGICAL

Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age

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.

Group Type: ACTIVE_COMPARATOR

IPV SSI

Intervention Type: BIOLOGICAL

Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age

Interventions

IPV-Al SSI

Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

IPV SSI

Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

Other Intervention Names

IPV Vaccine SSI

Eligibility Criteria

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)
• 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

• Minimum Eligible Age: 54 Days
• Maximum Eligible Age: 75 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Larix A/S

INDUSTRY

Sponsor Role: collaborator

Vaxtrials S.A.

OTHER

Sponsor Role: collaborator

AJ Vaccines A/S

INDUSTRY

Sponsor Role: collaborator

Statens Serum Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingrid Kromann

Role: STUDY_DIRECTOR

Statens Serum Institut

Locations

Cevaxin

Panama City, , Panama

Countries

Panama

References

Saez-Llorens X, Thierry-Carstensen B, Stoey LS, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months. Vaccine. 2020 May 6;38(21):3780-3789. doi: 10.1016/j.vaccine.2020.02.066. Epub 2020 Apr 6.

Reference Type: DERIVED

PMID: 32273184 (View on PubMed)

Other Identifiers

VIPV-07

Identifier Type: -

Identifier Source: org_study_id