CompletedNCT01061541Updated Sep 9, 2016

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

A Phase 2 interventional study of Tritanrix™-HepB low thio / and Hib 2.5 in Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline. Completed at 1 site in Philippines. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 192
Allocation: Randomized
Ages: 6 Weeks to 8 Weeks
Sex: All

Study 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 studied

Haemophilus Influenzae Type b

Keywords

Pertussis
Tetanus
Hiberix™
Hepatitis B
DTPw-HBV vaccine
Tritanrix™-HepB
Haemophilus influenzae type b
Diphtheria
Hib vaccine

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 8 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 192 participants (actual)

Study arms

Experimental
Group A
Biological: Tritanrix™-HepB low thio / · Biological: Hib 2.5 · Biological: Unconjugated Hib vaccine (plain PRP)
Active comparator
Group B
Biological: Tritanrix™-HepB · Biological: Hiberix™ · Biological: Unconjugated Hib vaccine (plain PRP)

Interventions

BiologicalTritanrix™-HepB low thio /
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BiologicalHib 2.5
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BiologicalTritanrix™-HepB
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BiologicalHiberix™
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BiologicalUnconjugated Hib vaccine (plain PRP)
One dose as intramuscular injection at 10 months of age

What researchers measure

Primary outcomes

anti-PRP antibody concentration above a protocol defined cut-off value.
Time frame: One month after the third dose of the primary vaccination course.

Secondary outcomes

anti-HBs antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-PRP antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-tetanus antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-diphtheria antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-Bordetella pertussis (BPT) antibody concentration
Time frame: One month after the third dose of the primary vaccination course
Vaccine response to Bordetella pertussis antigen.
Time frame: One month after the third dose of the primary vaccination course
Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
Time frame: Before the first dose of the primary vaccination course
anti-PRP antibody concentration
Time frame: Before and one month after the plain PRP challenge dose.
Occurrence of solicited symptoms
Time frame: During the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms
Time frame: During the 31-day follow-up period after each dose
Occurrence of serious adverse events
Time frame: Over the full course of the study

Study locations

1 site

GSK Investigational Site
Muntinlupa, 1781, Philippines

References and documents

Publications

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. PubMed 20657177 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01061541
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Feb 3, 2010
Start date: Aug 2003
Primary completion: Jan 2004
Completion: Aug 2004
Last update: Sep 9, 2016

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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