Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months

NCT03671616 | Completed Phase 3

• 1 other identifier: VIPV-07 E1
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Booster effect ratiors of GMT

  Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured before and one month after the booster vaccination

  Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2)

Secondary Outcomes (6)

• Seroprotection rates before booster vaccination

  6-9 months post-3rd vaccination

• Seroprotection rates after booster vaccination

  one month after booster vaccination

• GMT value before booster vaccination

  6-9 months post-3rd vaccination

• GMT value after booster vaccination

  one month after booster vaccination

• Number of adverse events

  6-9 months post-3rd vaccination and one month after booster vaccination

Study Arms (1)

IPV-Al SSI

EXPERIMENTAL

Single arm trial. All subjects will receive the IPV-Al SSI as booster vaccination

Biological: IPV-Al SSI

Interventions

IPV-Al SSI BIOLOGICAL

IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.

IPV-Al SSI

Eligibility Criteria

• Age: 15 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants having completed the VIPV-07 trial
• Healthy assessed from medical history and physical examination
• Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
• Parent(s)/guardian(s), according to the local legal requirements, have granted access to the infant's trial related medical records
• Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures

You may not qualify if:

• Previously vaccinated with OPV
• Previously vaccinated with IPV outside the VIPV-07 trial
• Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine)
• Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
• Previous Yellow Fever vaccination
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
• Participating in another interventional 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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: May 15, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PA (1)