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

NCT03025750 | Completed Phase 3 DMC

• 1 other identifier: VIPV-07
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants

  Change from baseline to one month after 3rd vaccination

Secondary Outcomes (5)

• Adverse events following vaccinations (key secondary)

  After primary injections at 2, 4 and 6 months of age

• Subjects with seroprotection against poliovirus types 1, 2 and 3

  One months after 3rd vaccination

• Subjects with poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody

  One months after 3rd vaccination

• Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3

  One months after 3rd vaccination

• Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3

  From baseline and one months after 3rd vaccination

Other Outcomes (7)

• Subject with seroconversion against poliovirus types 1, 2 and 3

  Two months after 2nd vaccination

• Subjects with seroprotection against poliovirus types 1, 2 and 3

  Two months after 2nd vaccination

• Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody

  Two months after 2nd vaccination

Study Arms (2)

IPV-Al SSI

EXPERIMENTAL

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.

Biological: IPV-Al SSI

IPV SSI

ACTIVE COMPARATOR

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.

Biological: IPV SSI

Interventions

IPV-Al SSI BIOLOGICAL

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

IPV-Al SSI

IPV SSI BIOLOGICAL

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

Also known as: IPV Vaccine SSI

IPV SSI

Eligibility Criteria

• Age: 54 Days - 75 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participating in another clinical trial

Sponsors & Collaborators

• Statens Serum Institut: lead
• Bill and Melinda Gates Foundation: collaborator
• Larix A/S: collaborator
• Vaxtrials S.A.: collaborator
• AJ Vaccines A/S: collaborator

Study Sites (1)

Cevaxin

Panama City, 0816-00383, Panama

Location

Related Publications (1)

• 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.

  PMID: 32273184 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Ingrid Kromann

  Statens Serum Institut

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: January 19, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)