Whole Cell PertussisPhase 3NCT00473668
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
A Phase 3 study testing Zilbrix-Hib and Tritanrix™-HepB/ Hiberix™ in people with Whole Cell Pertussis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in India.
Trial summary
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the… Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus
- What is being tested?
- Zilbrix-Hib and Tritanrix™-HepB/ Hiberix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesIndia
- Study dates
- 1 Jun 2007to 30 Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Administration of one dose of hepatitis B vaccine at birth
Who cannot join
- Use of any investigational or non-registered product (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 with the exception of OPV.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Hepatitis B vaccine received after the first week of life.
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
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- History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Trial locations and contacts
3 sites in 1 country.
India3 sites
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Kolkotta, 700072
GSK Investigational Site
Varanasi, 221005
About this study
Official title: Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Being tested
- Zilbrix-Hib, Tritanrix™-HepB/ Hiberix™
- Keywords
- Hepatitis B, Tetanus, Diphtheria, Pertussis, Haemophilus influenzae type b Vaccines
- Medical subject headings
- Haemophilus Infections, Tetanus, Diphtheria, Hepatitis B, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilbrix-HibBiological
Intramuscular injection, 1 dose
Tritanrix™-HepB/ Hiberix™Biological
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| TRITANRIX-HEPB/HIBERIX KFT. GROUP | Experimental | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. Receives: Biological: Zilbrix-Hib |
| TRITANRIX-HEPB/HIBERIX LD GROUP | Active comparator | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. Receives: Biological: Tritanrix™-HepB/ Hiberix™ |
| TRITANRIX-HEPB/HIBERIX HD GROUP | Active comparator | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. Receives: Biological: Tritanrix™-HepB/ Hiberix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Measured: At Month 3
Secondary outcomes (14)
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).
Measured: At Month 3
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).
Measured: At Month 3
Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off
Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.
Measured: At Month 3
Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).
Measured: At Month 3
Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen
A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).
Measured: At Month 3
Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen
Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.
Measured: At Month 3
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
Measured: At Month 3
Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: At Month 3
Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: At Month 3
Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Measured: At Month 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 4-day (Day 0-3) follow-up period post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Day 0-3) follow-up period post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Day 0-30) follow-up period post-vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (Day 0-Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study start1 Jun 2007
- Primary completion30 Jan 2008
- Study completion30 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whole Cell PertussisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473668
- Sponsor's protocol ID
- 104977
- Status last verified
- Mar 2017
- First submitted
- 14 May 2007
- Last updated
- 18 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Chatterjee S, Rego SJ, D'Souza F, Bhatia BD, Collard A, Datta SK, Jacquet JM. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010 Oct 15;10:298. doi: 10.1186/1471-2334-10-298.
PubMed 20950457
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age
- ClinicalTrials.gov ID
- NCT00473668
- Acronym / sponsor ID
- 104977
- Keywords
- Hepatitis B, Tetanus, Diphtheria, Pertussis, Haemophilus influenzae type b Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2007
- Primary completion
- 30 Jan 2008 (actual)
- Study completion
- 30 Jan 2008 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRITANRIX-HEPB/HIBERIX KFT. GROUP | Experimental | Biological: Zilbrix-HibSubjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX LD GROUP | Active comparator | Biological: Tritanrix™-HepB/ Hiberix™Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX HD GROUP | Active comparator | Biological: Tritanrix™-HepB/ Hiberix™Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Key exclusion criteria (15 listed)
- Use of any investigational or non-registered product (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 with the exception of OPV.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Hepatitis B vaccine received after the first week of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zilbrix-HibIntramuscular injection, 1 dose | Biological | TRITANRIX-HEPB/HIBERIX KFT. GROUP |
| Tritanrix™-HepB/ Hiberix™Intramuscular injection, 1 dose | Biological | TRITANRIX-HEPB/HIBERIX HD GROUP, TRITANRIX-HEPB/HIBERIX LD GROUP |
Primary outcome
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
Time frame: At Month 3
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
14 secondary outcomes
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Time frame: At Month 3
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen
Time frame: At Month 3
Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off
Time frame: At Month 3
Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
Time frame: At Month 3
Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen
Time frame: At Month 3
Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen
Time frame: At Month 3
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens
Time frame: At Month 3
Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens
Time frame: At Month 3
Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)
Time frame: At Month 3
Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen
Time frame: At Month 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-30) follow-up period post-vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0-Month 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20950457Chatterjee S, Rego SJ, D'Souza F, Bhatia BD, Collard A, Datta SK, Jacquet JM. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010 Oct 15;10:298. doi: 10.1186/1471-2334-10-298.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Whole Cell Pertussis
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Diptheria Immunization, Tetanus Immunization
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A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zilbrix-Hib and Tritanrix™-HepB/ Hiberix™ in people with Whole Cell Pertussis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in India.
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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens (time frame: At Month 3). 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 NCT00473668, 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 18 Aug 2017.