Study to Assess Safety & Immunogenicity of GSK Biological... | NCT00452686

Studies
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

NCT00452686

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

660

Phase

Phase 3

Conditions

Diphtheria
Acellular Pertussis
Tetanus

Interventions

Boostrix
Chinese DT vaccine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Mar 26, 2007

First Submission Date that Met QC Criteria

Mar 26, 2007

First Posted Date

Mar 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

660

Name	Type	Description	Arm Group Labels	Other Names
Boostrix	Biological
Chinese DT vaccine	Biological			Boostrix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

Secondary Outcomes

Measure	Description	Time Frame
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female between, and including, 6-8 years of age at the time of vaccination,
Written informed consent obtained from the parent or guardian of the subject,

Exclusion Criteria:

Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Suining			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20215881	Background	Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.

ID	Term
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D004165	Diphtheria
D013742	Tetanus