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

Healthy Clinical Trial

Official title:

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 Strains Compared to Conventional Salk IPV, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566940
• Other study ID #: CR108472
• Secondary ID: GV000051POL2001
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: August 2020
• Source: Janssen Vaccines & Prevention B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: October 17, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Days to 59 Days

Eligibility

Inclusion Criteria:

• Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14

• Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)

• Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant'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

• 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

• 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:

• Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders

• Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother

• Received polio vaccine or were previously infected with poliovirus

• Known or suspected autoimmune disease or persistent impairment/alteration of the immune function

• Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• sIPV
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
• cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.

Locations

Country	Name	City	State
Philippines	De La Salle Health Sciences Institute- DLSUMC	Dasmarinas
Philippines	De La Salle University Medical Center	Dasmarinas
Philippines	Philippine General Hospital	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Vaccines & Prevention B.V.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Events (AEs)	Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.	7 days after first vaccination
Primary	Number of Participants with Solicited Local and Systemic AEs	Number of participants with solicited local and systemic AEs will be determined up to 7 days after second vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.	7 days after second vaccination
Primary	Number of Participants with Solicited Local and Systemic AEs	Number of participants with solicited local and systemic AEs will be determined up to 7 days after third vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.	7 days after third vaccination
Primary	Number of Participants with Unsolicited AEs	Number of participants with unsolicited AEs will be determined up to 28 days after first vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).	28 days after first vaccination
Primary	Number of Participants with Unsolicited AEs	Number of participants with unsolicited AEs will be determined up to 28 days after second vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).	28 days after second vaccination
Primary	Number of Participants with Unsolicited AEs	Number of participants with unsolicited AEs will be determined up to 28 days after third vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).	28 days after third vaccination
Primary	Number of Participants with Serious Adverse Events (SAEs)	Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.	Approximately up to 36 weeks
Primary	Number of Participants Discontinued due to AEs	Number of participants discontinued from vaccinations or from the study due to AEs will be reported.	Approximately up to 36 weeks
Secondary	Percentage of Participants with Seroprotection	Percentage of participants with seroprotection will be reported. Seroprotection is defined as having a poliovirus neutralizing antibody (NAb) titer greater than or equal to (>=)8 at 28 days after the third vaccination for each poliovirus strain against Salk virus neutralization assay (VNA).	28 days after the third vaccination
Secondary	Percentage of Participants with Seroconversion	Percentage of participants with seroconversion will be reported. Seroconversion is defined as: 1) Pre-vaccination poliovirus NAb titer less than (<)8 and post-vaccination NAb >=8 at 28 days after the third vaccination for each poliovirus strain against Salk VNA, or 2) Pre-vaccination poliovirus NAb titer >=8 and post vaccination >=4 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.	28 days after the third vaccination
Secondary	Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses	Poliovirus NAb titers will be determined against the wild-type Salk strains (Type 1 [Mahoney], Type 2 [MEF-1] and Type 3 [Saukett]) as well as against the Sabin strains (Types 1, 2 and 3), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).	28 days after the third vaccination