Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

NCT ID: NCT01309646

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-04
• Study Completion Date: 2012-02-24

Brief Summary

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Conditions

Poliomyelitis; Tetanus; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Infanrix-IPV+Hib Group

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Group Type: EXPERIMENTAL

Infanrix™-IPV+Hib

Intervention Type: BIOLOGICAL

Intramuscular, 3 doses

Synflorix™

Intervention Type: BIOLOGICAL

Intramuscular, 3 doses

Rotarix™

Intervention Type: BIOLOGICAL

Oral, 2 doses

Infanrix IPV Group

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Group Type: ACTIVE_COMPARATOR

Infanrix™ IPV

Intervention Type: BIOLOGICAL

Intramuscular, 3 doses

Hiberix™

Intervention Type: BIOLOGICAL

Intramuscular, 3 doses

Synflorix™

Intervention Type: BIOLOGICAL

Intramuscular, 3 doses

Rotarix™

Intervention Type: BIOLOGICAL

Oral, 2 doses

Interventions

Infanrix™-IPV+Hib

Intramuscular, 3 doses

Intervention Type: BIOLOGICAL

Infanrix™ IPV

Intramuscular, 3 doses

Intervention Type: BIOLOGICAL

Hiberix™

Intramuscular, 3 doses

Intervention Type: BIOLOGICAL

Synflorix™

Intramuscular, 3 doses

Intervention Type: BIOLOGICAL

Rotarix™

Oral, 2 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
• Born after a gestation period of 37 to 42 weeks inclusive.
• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 69 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Goyang, , South Korea

GSK Investigational Site

GyeongSangNam-do, , South Korea

GSK Investigational Site

Iksan, , South Korea

GSK Investigational Site

Jeonju Jeonbuk, , South Korea

GSK Investigational Site

Seongnam-si, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon City, Gyeonggi-do, , South Korea

GSK Investigational Site

Uijeongbu, Gyeonggi-do, , South Korea

GSK Investigational Site

Wonju-si Kangwon-do, , South Korea

Countries

South Korea

References

Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.

Reference Type: BACKGROUND

PMID: 30431387 (View on PubMed)

Other Identifiers

2012-004137-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114260

Identifier Type: -

Identifier Source: org_study_id