A Study to Assess the Safety, Reactogenicity and Immunoge... | NCT03566940

ID	Type	Description	Link
GV000051POL2001	Other Identifier	Janssen Vaccines & Prevention B.V.

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Low Dose IPV Based on Sabin Strains (sIPV)	Experimental	Participants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age).	Biological: sIPV Biological: cIPV
Group 2: Intermediate Dose sIPV	Experimental	Participants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).	Biological: sIPV Biological: cIPV
Group 3: High Dose sIPV	Experimental	Participants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).	Biological: sIPV Biological: cIPV
Group 4: Conventional Salk IPV (cIPV)	Active Comparator	Participants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sIPV	Biological	Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.	Group 1: Low Dose IPV Based on Sabin Strains (sIPV) Group 2: Intermediate Dose sIPV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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).

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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)

Facility	Status	City	State	ZIP	Country	Contacts
De La Salle Health Sciences Institute- DLSUMC		Dasmariñas		4114	Philippines
De La Salle University Medical Center