AzTrials
AzTrials

Haemophilus Influenzae Type bPhase 2NCT01061541

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

A Phase 2 study testing Tritanrix™-HepB low thio /, Hib 2.5 and Tritanrix™-HepB in people with Haemophilus Influenzae Type b, run by GlaxoSmithKline at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 6 to 8 weeksHealthy volunteers can take part
Conditions the study is for
Haemophilus Influenzae Type b
What is being tested?
Tritanrix™-HepB low thio /, Hib 2.5 and Tritanrix™-HepB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 sitePhilippines
Study dates
Aug 2003to Aug 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • GSK Investigational Site

    City of Muntinlupa, 1781

Other trials in Philippines

About this study

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

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).

Being tested
Tritanrix™-HepB low thio /, Hib 2.5, Tritanrix™-HepB, Hiberix™, Unconjugated Hib vaccine (plain PRP)
Keywords
Pertussis, Tetanus, Hiberix™, Hepatitis B, DTPw-HBV vaccine, Tritanrix™-HepB, Haemophilus influenzae type b, Diphtheria, Hib vaccine
Medical subject headings
Haemophilus Infections, Whooping Cough, Tetanus, Hepatitis B, Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tritanrix™-HepB low thio /Biological

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

  • Hib 2.5Biological

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

  • Tritanrix™-HepBBiological

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

  • Hiberix™Biological

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

  • Unconjugated Hib vaccine (plain PRP)Biological

    One dose as intramuscular injection at 10 months of age

Study groups in NCT01061541
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Biological: Tritanrix™-HepB low thio /; Biological: Hib 2.5; Biological: Unconjugated Hib vaccine (plain PRP)
Group BActive comparatorNot described
Receives: Biological: Tritanrix™-HepB; Biological: Hiberix™; Biological: Unconjugated Hib vaccine (plain PRP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anti-PRP antibody concentration above a protocol defined cut-off value.

    Measured: One month after the third dose of the primary vaccination course.

Secondary outcomes (11)

  1. anti-HBs antibody concentration

    Measured: One month after the third dose of the primary vaccination course

  2. anti-PRP antibody concentration

    Measured: One month after the third dose of the primary vaccination course

  3. anti-tetanus antibody concentration

    Measured: One month after the third dose of the primary vaccination course

  4. anti-diphtheria antibody concentration

    Measured: One month after the third dose of the primary vaccination course

  5. anti-Bordetella pertussis (BPT) antibody concentration

    Measured: One month after the third dose of the primary vaccination course

  6. Vaccine response to Bordetella pertussis antigen.

    Measured: One month after the third dose of the primary vaccination course

  7. Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens

    Measured: Before the first dose of the primary vaccination course

  8. anti-PRP antibody concentration

    Measured: Before and one month after the plain PRP challenge dose.

  9. Occurrence of solicited symptoms

    Measured: During the 4-day follow-up period after each dose

  10. Occurrence of unsolicited symptoms

    Measured: During the 31-day follow-up period after each dose

  11. Occurrence of serious adverse events

    Measured: Over the full course of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study startAug 2003
  3. Primary completionJan 2004
  4. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061541
Sponsor's protocol ID
208108/091
Other IDs
208108/092
Status last verified
Sep 2016
First submitted
2 Feb 2010
Last updated
9 Sep 2016
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tritanrix™-HepB low thio /, Hib 2.5 and Tritanrix™-HepB in people with Haemophilus Influenzae Type b, run by GlaxoSmithKline at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

anti-PRP antibody concentration above a protocol defined cut-off value. (time frame: One month after the third dose of the primary vaccination course.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061541, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in