3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants

NCT02347423 | Completed Phase 2 DMC

• 2 other identifiers: VIPV-052014-003449-88
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

The background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third world countries. The intention of the present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the target population and do not decrease the immunogenicity clinically significantly compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of age. A total of 824 healthy infants will be included in the trial.

Conditions

Poliomyelitis

Keywords

Poliomyelitis immunization; primary series

Outcome Measures

Primary Outcomes (1)

• For each of the 3 poliovirus types 1, 2 and 3, for the IPV-Al and IPV Vaccine SSI vaccines to evaluate: Type specific seroconversion rates based on baseline and 4 weeks post 3rd vaccincation

  Change from baseline to 4 weeks post 3rd vaccincation

Secondary Outcomes (4)

• Type-specific geometric mean titers (GMTs)

  4 weeks post 3rd vaccination for each vaccine

• Type-specific seroprotection rates (titers ≥ 1/8)

  4 weeks post 3rd vaccination for each vaccine

• Type-specific reverse cumulative titer distribution curves based on pre-vaccination and 4 weeks post 3rd vaccination serum titers for each vaccine

  4 weeks post 3rd vaccination for each vaccine

• Adverse events following the vaccinations for each vaccine

  From inclusion to 4 weeks post 3rd vaccincation

Study Arms (4)

1/3 IPV-Al SSI

EXPERIMENTAL

3 vaccinations of 1/3 IPV-Al SSI given at 6, 10 and 14 weeks of age

Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI

1/5 IPV-Al SSI

EXPERIMENTAL

3 vaccinations of 1/5 IPV-Al SSI given at 6, 10 and 14 weeks of age

Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI

1/10 IPV-Al SSI

EXPERIMENTAL

3 vaccinations of 1/10 IPV-Al SSI given at 6, 10 and 14 weeks of age

Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI

IPV Vaccine SSI

ACTIVE COMPARATOR

3 vaccinations of IPV Vaccine SSI given at 6, 10 and 14 weeks of age, The comparator IPV Vaccine SSI contains: Type 1: 40DU, Type 2: 8 DU and Type 3: 32 DU.

Biological: IPV Vaccine SSI

Interventions

Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI BIOLOGICAL

1/10 IPV-Al SSI; 1/3 IPV-Al SSI; 1/5 IPV-Al SSI

IPV Vaccine SSI BIOLOGICAL

IPV Vaccine SSI

Eligibility Criteria

• Age: 42 Days - 49 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants of 6 weeks of age (+7 days) on date of first vaccination
• Healthy assessed from medical history and physical examination
• One parent/guardian has been properly informed about the trial and has signed the informed consent form
• One parent/guardian grants access to the infant's trial related medical records
• One parent/guardian is likely to comply with trial procedures

You may not qualify if:

• Has a sibling who is ≤5 years of age, and for whom OPV vaccination is planned during the trial
• Low birth weight (\< 2,500 g)
• Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency
• 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)
• Acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination
• 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
• Quintiles, Inc.: collaborator
• Larix A/S: collaborator

Study Sites (1)

Hospital Maternidad Nuestra de la Altagracia

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• Rivera L, Pedersen RS, Pena L, Olsen KJ, Andreasen LV, Kromann I, Nielsen PI, Sorensen C, Dietrich J, Bandyopadhyay AS, Thierry-Carstensen B. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial. Lancet Infect Dis. 2017 Jul;17(7):745-753. doi: 10.1016/S1473-3099(17)30177-9. Epub 2017 Apr 25.

  PMID: 28454674 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 26, 2015
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)