Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

NCT ID: NCT01061541

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-08-31

Brief Summary

In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.

Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).

Conditions

Haemophilus Influenzae Type b

Study Design

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

Study Groups

Group A

Group Type: EXPERIMENTAL

Tritanrix™-HepB low thio /

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Hib 2.5

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Unconjugated Hib vaccine (plain PRP)

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 10 months of age

Group B

Group Type: ACTIVE_COMPARATOR

Tritanrix™-HepB

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Hiberix™

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Unconjugated Hib vaccine (plain PRP)

Intervention Type: BIOLOGICAL

One dose as intramuscular injection at 10 months of age

Interventions

Tritanrix™-HepB low thio /

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Intervention Type: BIOLOGICAL

Hib 2.5

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Intervention Type: BIOLOGICAL

Tritanrix™-HepB

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Intervention Type: BIOLOGICAL

Hiberix™

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

Intervention Type: BIOLOGICAL

Unconjugated Hib vaccine (plain PRP)

One dose as intramuscular injection at 10 months of age

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.
• A male or female between, and including, 6 and 8 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.
• Born after a gestation period of 36 to 42 weeks.
• Born to a mother proven seronegative for HBsAg.

Exclusion Criteria

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
• Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
• Use of any investigational or non-registered 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 since birth.
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
• 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.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 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

City of Muntinlupa, , Philippines

Countries

Philippines

References

Gatchalian SR, Ramakrishnan G, Bock HL, Lefevre I, Jacquet JM. Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children. Hum Vaccin. 2010 Aug;6(8):664-72. doi: 10.4161/hv.6.8.12155.

Reference Type: DERIVED

PMID: 20657177 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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. The results of this study 208108/091 are summarised with study 208108/092 on 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: Informed Consent Form

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: Study Protocol

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

208108/092

Identifier Type: OTHER

Identifier Source: secondary_id

208108/091

Identifier Type: -

Identifier Source: org_study_id