Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months

NCT03032419 | Completed Phase 3 DMC

• 1 other identifier: VIPV-06
• Study Type: interventional
• Target: 1,002
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline to one month after 3rd vaccination

Secondary Outcomes (7)

• Adverse event 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 seroprotection against poliovirus types 1, 2 and 3

  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

  One months after 3rd vaccination

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

  One months after 3rd vaccination

Other Outcomes (7)

• Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres

  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

  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

  Before and one month after 4th vaccination

Study Arms (2)

IPV-Al SSI

EXPERIMENTAL

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

Biological: IPV-Al SSI

IPV SSI

ACTIVE COMPARATOR

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

Biological: IPV SSI

Interventions

IPV-Al SSI BIOLOGICAL

3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

IPV-Al SSI

IPV SSI BIOLOGICAL

3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

Also known as: IPV Vaccine SSI

IPV SSI

Eligibility Criteria

• Age: 6 Weeks - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
• Healthy assessed from medical history and physical examination
• 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
• Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
• Parent(s)/guardian(s) granting access to the infant's trial related medical records
• Parent(s)/guardian(s) likely to comply with the 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
• Syneos Health: collaborator
• AJ Vaccines A/S: collaborator

Study Sites (1)

5 sites in Philippines

Manila, Philippines

Location

Related Publications (1)

• Bravo LC, Carlos JC, Gatchalian SR, Montellano MEB, Tabora CFCB, Thierry-Carstensen B, Tingskov PN, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age. Vaccine. 2020 Jan 16;38(3):530-538. doi: 10.1016/j.vaccine.2019.10.064. Epub 2019 Nov 5.

  PMID: 31703934 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 26, 2017
• Study Start: February 6, 2017
• Primary Completion: September 21, 2017
• Study Completion: March 12, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

PH (1)