Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

NCT ID: NCT00316147

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-08-31

Brief Summary

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

• one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
• the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

Detailed Description

DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 & Haemophilus influenzae type b vaccine

Conditions

Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis

Study Design

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

Interventions

DTPa-HBV-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Born after a normal gestation period (between 36 and 42 weeks).
• Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.

Exclusion Criteria

• Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
• Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 10 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

Bangalore, , India

GSK Investigational Site

Baroda, , India

GSK Investigational Site

Goa, , India

GSK Investigational Site

New Delhi, , India

Countries

India

Study Documents

Document Type: Dataset Specification

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: Informed Consent Form

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

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

104005

Identifier Type: -

Identifier Source: org_study_id