Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

NCT ID: NCT00325143

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 702 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-01
• Study Completion Date: 2007-02-01

Brief Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Conditions

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

Study Design

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

Study Groups

Infanrix Hexa Group

Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.

Group Type: EXPERIMENTAL

DTPa-HBV-IPV/Hib

Intervention Type: BIOLOGICAL

1 intramuscular injection (3rd study vaccine dose)

DTPa-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Interventions

DTPa-HBV-IPV/Hib

1 intramuscular injection (3rd study vaccine dose)

Intervention Type: BIOLOGICAL

DTPa-IPV/Hib vaccine

3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Intervention Type: BIOLOGICAL

Other Intervention Names

INFANRIX HEXA™

Eligibility Criteria

Inclusion Criteria

• Subjects must have been enrolled in the Rota-028 study.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion Criteria

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 the vaccine and ending 30 days after.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• 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

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

Countries

Singapore

References

Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47.

Reference Type: BACKGROUND

PMID: 21323176 (View on PubMed)

Study Documents

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: Dataset Specification

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

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

217744/100

Identifier Type: -

Identifier Source: org_study_id