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

NCT ID: NCT01086423

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 985 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2010-11-19

Brief Summary

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Conditions

Tetanus; Poliomyelitis; 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 1 GROUP

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.

Group Type: EXPERIMENTAL

Infanrix-IPV/Hib™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

INFANRIX-IPV+HIB 2 GROUP

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.

Group Type: EXPERIMENTAL

Infanrix-IPV/Hib™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

INFANRIX-HIB+POLIORIX GROUP

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.

Group Type: ACTIVE_COMPARATOR

Infanrix Hib™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Poliorix™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Interventions

Infanrix-IPV/Hib™

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Infanrix Hib™

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Poliorix™

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
• Born after a gestation period of 36 to 42 weeks, inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Child in care.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B 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/or Haemophilus influenzae type b (Hib) disease or vaccination.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.

• Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 90 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

Wuzhou, Guangxi, China

GSK Investigational Site

Wuzhou, Guangxi, China

Countries

China

Other Identifiers

112584

Identifier Type: -

Identifier Source: org_study_id