Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

NCT ID: NCT00696423

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-07
• Study Completion Date: 2008-07-26

Brief Summary

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 = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

Conditions

Acellular Pertussis; Diphtheria; Tetanus

Study Design

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

Study Groups

Infanrix/Hib Single Injection Group

Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.

Group Type: EXPERIMENTAL

Infanrix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Hiberix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Infanrix + Hiberix Separate Injection Group

Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.

Group Type: ACTIVE_COMPARATOR

Infanrix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Hiberix™

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Interventions

Infanrix™

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

Hiberix™

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects should have completed the full three-dose primary vaccination course in study 104567.
• A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
• Written informed consent obtained from the parent or guardian 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use during the study period.
• Chronic administration (defined as more than 14 days) 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 vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
• 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.
• Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
• History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any progressive neurological disorders or seizures.
• Acute disease and/or fever at time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of any of the following adverse events (AEs) after previous administration of a diphtheria-tetanus-pertussis (DTP) vaccine:

• Hypersensitivity reaction due to any component of the vaccine.
• Encephalopathy.
• Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination.
• 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.

• 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

Liucheng County, Guangxi, China

GSK Investigational Site

Mengshan, , China

GSK Investigational Site

Wuzhou, , China

Countries

China

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

111535

Identifier Type: -

Identifier Source: org_study_id