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

NCT00696423 | Completed Phase 3 Results

• 1 other identifier: 111535
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 3

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

Keywords

Infanrix/Hib; Chinese children

Outcome Measures

Primary Outcomes (5)

• Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations

  Geometric mean concentrations are given in microgram per milliliter (μg/mL).

  One month after booster vaccination

• Anti-diphtheria Toxoid Antibody Concentrations

  Geometric mean concentrations are given in international Unit per milliliter (IU/mL).

  One month after booster vaccination

• Anti-tetanus Toxoid Antibody Concentrations

  Geometric mean concentrations are given in IU/mL.

  One month after booster vaccination

• Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations

  Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

  One month after booster vaccination

• The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies

  Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.

  One month after booster vaccination

Secondary Outcomes (8)

• Anti-PRP Antibody Concentrations

  Before booster vaccination

• Anti-diphtheria Toxoid Antibody Concentrations

  Before booster vaccination

• Anti-tetanus Toxoid Antibody Concentrations

  Before booster vaccination

• Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

  Before booster vaccination

• The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies

  Before booster vaccination

Study Arms (2)

Infanrix/Hib Single Injection Group

EXPERIMENTAL

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

Biological: Infanrix™; Biological: Hiberix™

Infanrix + Hiberix Separate Injection Group

ACTIVE COMPARATOR

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

Biological: Infanrix™; Biological: Hiberix™

Interventions

Infanrix™ BIOLOGICAL

Intramuscular injection, one dose

Infanrix + Hiberix Separate Injection Group; Infanrix/Hib Single Injection Group

Hiberix™ BIOLOGICAL

Intramuscular injection, one dose

Infanrix + Hiberix Separate Injection Group; Infanrix/Hib Single Injection Group

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Liucheng County, Guangxi, 545200, China

Location

GSK Investigational Site

Mengshan, China

Location

GSK Investigational Site

Wuzhou, China

Location

Related Links

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

MeSH Terms

Conditions

Diphtheria; Tetanus

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Hiberix

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 12, 2008
• Study Start: June 7, 2008
• Primary Completion: July 26, 2008
• Study Completion: July 26, 2008
• Last Updated: June 6, 2018
• Results First Posted: August 26, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)