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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01061541
First received: February 2, 2010
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Haemophilus Influenzae Type b
Biological: Tritanrix™-HepB low thio /
Biological: Hib 2.5
Biological: Tritanrix™-HepB
Biological: Hiberix™
Biological: Unconjugated Hib vaccine (plain PRP)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • anti-PRP antibody concentration above a protocol defined cut-off value. [ Time Frame: One month after the third dose of the primary vaccination course. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anti-HBs antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • anti-PRP antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • anti-tetanus antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • anti-diphtheria antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • anti-Bordetella pertussis (BPT) antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Vaccine response to Bordetella pertussis antigen. [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens [ Time Frame: Before the first dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • anti-PRP antibody concentration [ Time Frame: Before and one month after the plain PRP challenge dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after each dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each dose ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Over the full course of the study ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: August 2003
Study Completion Date: August 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Tritanrix™-HepB low thio /
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
Biological: Hib 2.5
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
Biological: Unconjugated Hib vaccine (plain PRP)
One dose as intramuscular injection at 10 months of age
Active Comparator: Group B Biological: Tritanrix™-HepB
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
Biological: Hiberix™
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
Biological: Unconjugated Hib vaccine (plain PRP)
One dose as intramuscular injection at 10 months of age

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061541

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01061541     History of Changes
Other Study ID Numbers: 208108/091, 208108/092
Study First Received: February 2, 2010
Last Updated: June 26, 2014
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
Pertussis
Tetanus
Hiberix™
Hepatitis B
DTPw-HBV vaccine
Tritanrix™-HepB
Haemophilus influenzae type b
Diphtheria
Hib vaccine

ClinicalTrials.gov processed this record on September 18, 2014