Submitted by: Margarett Lerin 2018-06-18 00:00:00 Last Updated by: Margarett Lerin 2019-05-24 16:35:27 Export to PDF

A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of age Immunization Schedule

PHRR180621-001844

CTA-2018-04-06-12

2018-CT0444

A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin [sIPV] Strains Compared to Conventional Salk IPV [cIPV], in a 6, 10 and 14 Weeks of age Immunization Schedule, and Co-administered with Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines Ptotocol # GV000051POL2001

The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.

Regime Classification Priority
2017 - 2022 Responsive health systems Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-07-06 18 2020-01-06 0000-00-00

Ongoing

Institution Classification Region LTO #
Janssen Vaccines & Prevention B.V. Private Business Netherlands NA
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Amount Region
Janssen Vaccines & Prevention B.V. N/A Netherlands
Name E-Mail Phone Number Postal Address
Guia Marie Ramirez GuiaMarie.Ramirez@parexel.com 632 988 6285 PAREXEL Clinical Research (Phils.) Ltd Corp 15th Flr. PhilamLife Tower 8767 Paseo de Roxas 1226 Makati City Philippines
Name E-Mail Phone Number Postal Address
Ariel Hernandez, MD Ariel.Hernandez@parexel.com 632 988 6277 PAREXEL Clinical Research (Phils.) Ltd Corp 15th Flr. PhilamLife Tower 8767 Paseo de Roxas 1226 Makati City Philippines
Name Expertise Affiliation
Anna Lisa Ong-Lim, MD Principal Investigator Philippine General Hospital
Mitzi Trinidad-Aseron, MD Principal Investigator De La Salle Health Sciences Institute
Salvacion R. Gatchalian, MD Principal Investigator Philippine General Hospital
Delia Caparas-Yu, MD Principal Investigator De La Salle Health Sciences Institute
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee

Prophylactic active immunization against poliomyelitis disease

Safety and reactogenicity of different doses of sIPV and cIPV, administered at 6, 10 and 14 weeks of age, defined as:
· Solicited local and systemic adverse events (AEs) for 7 days following each vaccination.
· Unsolicited AEs for 28 days following each vaccination
· Serious AEs (SAEs) throughout the study
· Discontinuations from vaccinations or from the study due to AEs

Immunogenicity of different doses of sIPV and cIPV defined as:
*Seroprotection, defined as having a poliovirus neutralizing antibody (NAb) titer ≥8 at 28 days after the third vaccination for each poliovirus strain against Salk virus neutralization assay (VNA).
*Seroconversion, defined as19:

  •  Pre-vaccination poliovirus NAb titer
  • Pre-vaccination poliovirus NAb titer 28 and post vaccination 24-fold increase in poliovirus NAb titer (with correction for maternal-antibody decline at Week 18, with a half-life of maternal antibodies of 1 month), at 28 days after the third vaccination for each poliovirus strain against Salk VNA.

*Poliovirus NAb titers at 28 days after the third vaccination for each poliovirus strain against Sabin VNA, identifying seroprotection and seroconversion as defined for the Salk VNA determinations.

Completed

  • Philippines
  • Thailand

Clinical Trial

20180308094656

2018-06-07

Date Amendment Classification Reason
2018-11-26 Amendments related to the protocol Informed consent

Inclusion criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. Each study participant’s legally acceptable representative (per local regulations) must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study before performing any assessments.
2. Study participant is a boy or a girl, who is eligible for EPI vaccinations (ie, IPV, DTwP-Hib-HBV and PCV13) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14.
3. Study participant was born after a normal term pregnancy (237 weeks) and with a birth weight of 22.5 kg.
4. Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, HBV, hepatitis C virus status or other significant disease that might impact the infant’s health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing.
5. Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
6. Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window.
Exclusion criteria
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Contraindication to IM injections and blood draws (venipuncture) eg, bleeding disorders.
2. Any significant acute or chronic illness within 3 days prior to randomization and/or fever (higher than or equal to 38.0°C [100.4°F], preferably axillary) within 1 day prior to randomization. An infant with a minor illness (such as mild diarrhea, mild upper respiratory tract infection) without fever or benign fever convulsions may be enrolled at the discretion of the investigator.
3. Known allergies, hypersensitivity, or intolerance to 1 of the excipients of sIPV or cIPV or any other vaccine component in the infant or mother.
4. Is being breastfed and the mother is taking any therapies that in the opinion of the investigator could limit or confound the protocol-specified assessments.
5. Study participant with a weight below the tenth percentile for weight and height according to the WHO growth chart at the time of enrollment.20 (See Attachment 1)
6. Is currently enrolled or is planning participation in another interventional study during the course of this study.
7. Received or plans to receive a licensed live attenuated vaccine within 28 days or licensed not live (eg, inactivated or conjugate) vaccine within 14 days before randomization until 28 days
after the last planned administration of study vaccine and co-administered vaccines (ie, DTwP-Hib-HBV vaccines, PCV13 and Rotavirus vaccine) at 16 weeks of age.
8. Received polio vaccine or were previously infected with polivirus.
9. The study participant or their legally acceptable representative, are a family member or employee of site staff with direct involvement in the proposed study.
10. Study participant’s legally acceptable representative, is not able to communicate reliably with the investigator.
11. Chronic administration of immunosuppressants or other immune modifying drugs since birth.
12. Received a blood transfusion, treatment with immunoglobulins or blood from birth to before the administration of the first dose of study vaccine or is planned to receive such treatment during the study.
13. Known or suspected autoimmune disease or persistent impairment/alteration of the immune function.
14. Known neurological disease including seizures, congenital defects, or genetic disorders (eg, Down syndrome).
15. Study participant will travel to any country still encountering polio disease, eg, Afghanistan, Pakistan, during the study.
16. Study participant from whom no adequate blood sample, minimum 2 mL of blood, for baseline immunology assessment can be acquired.
17. Study participant for whom a household member/sibling has received or is scheduled to receive OPV in the 3 months preceding or 5 weeks following the third vaccination (Visit 4).
18. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the study participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Interventional

sIPV (JNJ-64152348) and cIPV

 

Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.

Participants will receive 0.5 mL of cIPV as a suspension for IM injection.

Randomized

Unspecified

Unspecified

Parallel

The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control

Phase II

300

300

Unspecified

06 Jul 2018

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