Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

NCT ID: NCT00320463

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-01-31

Brief Summary

In this study, infants will be randomly allocated into three groups:

• one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
• the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
• the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Detailed Description

A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

Conditions

Diphtheria; Hepatitis B; Poliomyelitis; Tetanus; Acellular Pertussis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

DTPa-HBV-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
• Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
• Born after a normal gestation period (between 36 and 42 weeks).
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
• Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

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• Minimum Eligible Age: 11 Weeks
• Maximum Eligible Age: 17 Weeks
• 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

Murmansk, , Russia

GSK Investigational Site

Perm, , Russia

GSK Investigational Site

Syktyvkar, , Russia

GSK Investigational Site

Syktyvkar, , Russia

Countries

Russia

Study Documents

Document Type: Clinical Study Report

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

View Document

Document Type: Study Protocol

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: Statistical Analysis Plan

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

105910

Identifier Type: -

Identifier Source: org_study_id