Submitted by: John Michael Dominic Go 2017-05-25 00:00:00 Last Updated by: John Michael Dominic Go 2017-09-13 16:12:31 Export to PDF

Clinical trial of reduced dose inactivated polio vaccine, IPV-Al SSI, in comparison to non-adjuvanted full dose IPV SSI, in infants

PHRR170525-001548

VIPV-06

2016-CT0359

Safety and immunogenicity of adjuvanted reduced dose inactivated polio vaccine, IPV-Al SSI, in comparison to non-adjuvanted full dose IPV SSI, in infants vaccinated at 6, 10, 14 weeks and 9 months of age

The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicenter clinical trial with 2 parallel groups:
•IPV-Al SSI (investigational vaccine)
•IPV SSI (reference vaccine)

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-01-24 12 2018-01-24 0000-00-00

Ongoing

Institution Classification Region LTO #
Statens Serum Institut Private Business Denmark N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Amount Region
Statens Serum Institut N/A Denmark
Name E-Mail Phone Number Postal Address
Genevieve Baisa genevieve.baisa@incresearch.com +6324647008 Pasig City, Philippines
Name E-Mail Phone Number Postal Address
Pernille Nyholm Tingskov PNT@ssi.dk 3268 8505 5 Artillerivej, DK-2300 Copenhagen, Denmark
Name Expertise Affiliation
Lulu C. Bravo, MD Pediatrician Philippine General Hospital
Charissa Fay C. Borja-Tabora, MD Pediatrician Research Institute for Tropical Medicine
Salvacion R. Gatchalian, MD Pediatrician Philippine General Hospital
May Emmeline Montellano, MD Pediatrician Mary Chiles General Hospital
Josefina B. Cadorna-Carlos, MD Pediatrician University of the East Ramon Magsaysay Memorial Medical Center
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Mary Chiles General Hospital Mary Chiles General Hospital Ethics Review Committee
University of the East Ramon Magsaysay Memorial Medical Center N/A

Poliomyelitis

To demonstrate the non-inferiority of seroconversion for poliovirus types 1, 2 and 3 for IPV-Al SSI compared to IPV SSI in infants one month after the 3rd vaccination.

To describe and compare between IPV-Al SSI and IPV SSI the safety profiles of the vaccines

Completed

  • Philippines

Clinical Trial

20160518165635

2016-09-15

None

INCLUSION CRITERIA
 
1. Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
2. Healthy assessed from medical history and physical examination
3. 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
4. Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
5. Parent(s)/guardian(s) granting access to the infant's trial related medical records
6. Parent(s)/guardian(s) likely to comply with the trial procedures
 
EXCLUSION CRITERIA
 
1. Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
2. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 month prior to inclusion or planned during the trial
3. Low birth weight (< 2,500 g)
4. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
5. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
6. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
8. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial
9. Participating in another clinical trial
10. Not suitable for inclusion in the opinion of the investigator

Interventional

IPV-Al-SSI

0.5 mL is injected intramuscularly perpendicular to the skin in the anterolateral aspect of the RIGHT thigh by use of a hypodermic needle.

Randomized

Single Blind

This phase III clinical trial is observer-blinded. The identity of the trial vaccine administered to a trial subject will remain unknown to the: - parents of the vaccinated subject - staff performing the safety assessments at the investigational site - staff performing the polio antibody analysis  - clinical trial manager - staff performing data management and statistical tasks, except for staff responsible for the randomisation code and involved in DSMB requirements.

Parallel

To demonstrate the non-inferiority of seroconversion for poliovirus types 1, 2 and 3 for IPV-Al SSI compared to IPV SSI in infants one month after the 3rd vaccination.

Phase III

1000

Unspecified

Unspecified

24 Jan 2017

Utilization Utilization Info
No records found.

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