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

Haemophilus Influenzae Type b Clinical Trial

Official title:

A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061541
• Other study ID #: 208108/091
• Secondary ID: 208108/092
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2010
• Last updated: September 8, 2016
• Start date: August 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 8 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b

Intervention

Biological:
• Tritanrix™-HepB low thio /
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
• Hib 2.5
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
• Tritanrix™-HepB
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
• Hiberix™
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
• Unconjugated Hib vaccine (plain PRP)
One dose as intramuscular injection at 10 months of age

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-PRP antibody concentration above a protocol defined cut-off value.		One month after the third dose of the primary vaccination course.	No
Secondary	anti-HBs antibody concentration		One month after the third dose of the primary vaccination course	No
Secondary	anti-PRP antibody concentration		One month after the third dose of the primary vaccination course	No
Secondary	anti-tetanus antibody concentration		One month after the third dose of the primary vaccination course	No
Secondary	anti-diphtheria antibody concentration		One month after the third dose of the primary vaccination course	No
Secondary	anti-Bordetella pertussis (BPT) antibody concentration		One month after the third dose of the primary vaccination course	No
Secondary	Vaccine response to Bordetella pertussis antigen.		One month after the third dose of the primary vaccination course	No
Secondary	Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens		Before the first dose of the primary vaccination course	No
Secondary	anti-PRP antibody concentration		Before and one month after the plain PRP challenge dose.	No
Secondary	Occurrence of solicited symptoms		During the 4-day follow-up period after each dose	No
Secondary	Occurrence of unsolicited symptoms		During the 31-day follow-up period after each dose	No
Secondary	Occurrence of serious adverse events		Over the full course of the study	No

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