Clinical trial NCT02458183: Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
Official title: A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 476
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

Detailed description: A multinational, multicenter, randomized, comparative, open-label, phase 3 study

Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products

Eligibility criteria: Inclusion Criteria:

* Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
* Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
* Male and female infants who are identified to be healthy based on physical examination and medical history.

Exclusion Criteria:

* Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
* Subjects who have moderate or severe acute disease (regardless of fever).
* Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
* Subjects who have major congenital defects.
* Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
* Subjects who have abnormalities in the immune system, or congenital/acquired immune deﬁciency.
* Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
* Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
* Subjects who are allergic to the ingredients of the investigational products.
* Subjects who have received immunoglobulins or blood products or plan to get those medications.
* Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
* Subjects who are currently participating or planning to participate in other clinical studies during the study period.
* Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.

Primary outcomes:
measure: Vaccine response rate
timeFrame: 4 weeks after the three-dose primary vaccination
Secondary outcomes:
measure: Geometric mean titer (GMT)
timeFrame: 4 weeks after the three-dose primary vaccination
Other outcomes:
measure: Solicited adverse event/adverse drug reaction
timeFrame: 24~26 weeks after the final vaccination
measure: Unsolicited adverse event/adverse drug reaction
timeFrame: 24~26 weeks after the final vaccination
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: KeiMyung University Dongsan Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Gwangmyeong Sungae Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulgi General Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Sevrance Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: KEPCO Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Sevrance Christian Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Thammasat University
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: HJ Jung
role: STUDY_DIRECTOR
References: