Clinical trial NCT03566940: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 302
Sex: ALL
Minimum age (years): 39
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
timeFrame: 7 days after first vaccination
measure: Number of Participants with Solicited Local and Systemic AEs
timeFrame: 7 days after second vaccination
measure: Number of Participants with Solicited Local and Systemic AEs
timeFrame: 7 days after third vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days after first vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days after second vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days after third vaccination
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Approximately up to 36 weeks
measure: Number of Participants Discontinued due to AEs
timeFrame: Approximately up to 36 weeks
Secondary outcomes:
measure: Percentage of Participants with Seroprotection
timeFrame: 28 days after the third vaccination
measure: Percentage of Participants with Seroconversion
timeFrame: 28 days after the third vaccination
measure: Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
timeFrame: 28 days after the third vaccination
Other outcomes:
Locations:
city: Dasmarinas
country: Philippines
facility: De La Salle Health Sciences Institute- DLSUMC
city: Dasmarinas
country: Philippines
facility: De La Salle University Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: