Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

NCT ID: NCT01449812

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 831 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-01
• Study Completion Date: 2012-01-16

Brief Summary

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).

Conditions

Acellular Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Type b

Study Design

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

Study Groups

INFANRIX+HIB/POLIORIX 1 GROUP

Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.

Group Type: EXPERIMENTAL

Infanrix+Hib™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

Poliorix™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

INFANRIX+HIB/POLIORIX 2 GROUP

Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.

Group Type: EXPERIMENTAL

Infanrix+Hib™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

Poliorix™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

CONTROL GROUP

Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.

Group Type: ACTIVE_COMPARATOR

Infanrix+Hib™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

Poliorix™

Intervention Type: BIOLOGICAL

Intramuscular, one dose

Interventions

Infanrix+Hib™

Intramuscular, one dose

Intervention Type: BIOLOGICAL

Poliorix™

Intramuscular, one dose

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa /Hib; IPV

Eligibility Criteria

Inclusion Criteria

• A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
• Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
• Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
• Written informed consent obtained from the parent(s)/LAR(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 booster dose of the study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
• Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
• Serious chronic illness.
• Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
• Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
• Encephalopathy
• Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
• Collapse or shock-like state within 48 hours of vaccination.
• Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
• Seizures with or without fever occurring within 3 days of vaccination.

• Acute disease and/or fever at the time of enrolment.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 24 Months
• 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

114386

Identifier Type: -

Identifier Source: org_study_id