Whole Cell PertussisPhase 3NCT00169442
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
A Phase 3 study testing Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™ and Hiberix™ in people with Whole Cell Pertussis and Diphtheria, run by GlaxoSmithKline at 3 sites in Philippines.
Trial summary
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age. Read more about this study
- Who is it for?
- Ages 10 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Whole Cell Pertussis, Diphtheria, Hepatitis B
- What is being tested?
- Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™ and Hiberix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 745 participants
- Where
- 3 sitesPhilippines
- Study dates
- 10 Feb 2005to 10 Mar 2006
- 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 10 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For subjects receiving Plain PRP followed by DTPw-HBV:
- Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:
- Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- For all subjects:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Free of obvious health problems as established by medical history and clinical examination
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites
GSK Investigational Site
City of Muntinlupa, 1781
GSK Investigational Site
Pasay
GSK Investigational Site
Quezon City, 1109
About this study
Official title: Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Read the detailed description
- Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.
- Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
- Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.
- Being tested
- Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™, Hiberix™, Polyribosil-Ribitol-Phosphate (PRP) vaccine, Tritanrix™-HepB Kft
- Medical subject headings
- Diphtheria, Hepatitis B, Tetanus, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanrix™-HepB/Hiberix™ Kft.Biological
Also called DTPw-HBV/Hib Kft
GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
Tritanrix™-HepB/Hiberix™Biological
Also called DTPw-HBV/Hib
GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
Hiberix™Biological
GSK Biologicals' Haemophilus influenzae type b vaccine
Polyribosil-Ribitol-Phosphate (PRP) vaccineBiological
plain PRP polysaccharide vaccine
Tritanrix™-HepB KftBiological
Also called DTPw-HBV Kft
GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
| Study group | Role | What they receive |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Mix Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. Receives: Biological: Tritanrix™-HepB/Hiberix™ Kft. |
| Tritanrix-HepB/Hiberix Kft. Ref Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. Receives: Biological: Tritanrix™-HepB/Hiberix™ Kft.; Biological: Tritanrix™-HepB/Hiberix™ |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. Receives: Biological: Tritanrix™-HepB/Hiberix™ Kft. |
| Tritanrix-HepB Kft.+Hiberix Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age. Receives: Biological: Hiberix™; Biological: Tritanrix™-HepB Kft |
| PRP Tritanrix-HepB Kft. Mix Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. Receives: Biological: Tritanrix™-HepB/Hiberix™ Kft.; Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine; Biological: Tritanrix™-HepB Kft |
| PRP Tritanrix-HepB Kft. Ref Group | Experimental | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. Receives: Biological: Tritanrix™-HepB/Hiberix™; Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine; Biological: Tritanrix™-HepB Kft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.
Measured: At Month 1, post-PRP challenge
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.
Measured: At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).
Measured: At Month 1, post-booster vaccination
Seroprotection Rates for Anti-D Antibodies
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Measured: At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).
Measured: At Month 1, post-booster vaccination
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).
Measured: At Month 1, post-booster vaccination
Number of Subjects With Booster Response to BPT Antigen
The booster response was defined as:
- an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or
- at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.
Measured: At Month 1, post-booster vaccination
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Measured: At Month 1, post-PRP challenge
Anti-PRP Antibody Concentrations.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Measured: At Month 1, post-booster vaccination
Anti-D and Anti-T Antibody Concentrations
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Measured: At Month 1, post-booster vaccination
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Measured: At Month 1, post-booster vaccination
Anti-BPT Antibody Concentrations
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
Measured: At Month 1, post-booster vaccination
Secondary outcomes (17)
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.
Measured: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.
Measured: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Seroprotection Rates for Anti-D Antibodies
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.
Measured: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.
Measured: At Month 0, prior to the PRP challenge
Anti- PRP Antibody Concentrations
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Anti- PRP Antibody Concentrations.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Anti-D and Anti-T Antibody Concentrations.
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Anti-HBs Antibody Concentrations.
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Anti-BPT Antibody Concentrations.
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
Measured: At Month 0, prior to the PRP challenge
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the 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 (Days 0-3) post-PRP challenge
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 the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-Day (Days 0-3) post-PRP challenge
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the 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 (Days 0-3) post-booster vaccination period
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 the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-Day (Days 0-3) post-booster vaccination period
Number of Subjects With 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
Number of Subjects With Serious Adverse Events (SAEs)
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 (from Month 0 to Month 9.5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start10 Feb 2005
- Primary completion1 Mar 2006
- Study completion10 Mar 2006
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 (2)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
- None (open label)
- Enrolment
- 745 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
- NCT00169442
- Sponsor's protocol ID
- 104065
- Status last verified
- May 2017
- First submitted
- 12 Sep 2005
- Last updated
- 6 Jun 2018
- 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
Gatchalian et al. A new DTPw-HBV/Hib vaccine: Immunogenic and safe for primary vaccination and booster dosing in the second year of life - 5th World Congress WSPID, Bangkok, Thailand, 15-18 Nov 2007
Gatchalian S, Reyes M, Bermal N, Chandrasekaran V, Han HH, Bock HL, Lefevre I. A new DTPw-HBV/Hib vaccine: immune memory after primary vaccination and booster dosing in the second year of life. Hum Vaccin. 2008 Jan-Feb;4(1):60-6. doi: 10.4161/hv.4.1.5069. Epub 2007 Sep 23.
PubMed 18376148
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib
- ClinicalTrials.gov ID
- NCT00169442
- Acronym / sponsor ID
- 104065
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2005 (actual)
- Primary completion
- 1 Mar 2006 (actual)
- Study completion
- 10 Mar 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Detailed description
- Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.
- Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
- Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Mix Group | Experimental | Biological: Tritanrix™-HepB/Hiberix™ Kft.Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| Tritanrix-HepB/Hiberix Kft. Ref Group | Experimental | Biological: Tritanrix™-HepB/Hiberix™ Kft., Biological: Tritanrix™-HepB/Hiberix™Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Experimental | Biological: Tritanrix™-HepB/Hiberix™ Kft.Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| Tritanrix-HepB Kft.+Hiberix Group | Experimental | Biological: Hiberix™, Biological: Tritanrix™-HepB KftHealthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age. |
| PRP Tritanrix-HepB Kft. Mix Group | Experimental | Biological: Tritanrix™-HepB/Hiberix™ Kft., Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine, Biological: Tritanrix™-HepB KftHealthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| PRP Tritanrix-HepB Kft. Ref Group | Experimental | Biological: Tritanrix™-HepB/Hiberix™, Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine, Biological: Tritanrix™-HepB KftHealthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
Who may qualify
- Ages
- 10 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Free of obvious health problems as established by medical history and clinical examination
Key exclusion criteria (3 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
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 |
|---|---|---|
| Tritanrix™-HepB/Hiberix™ Kft.Also: DTPw-HBV/Hib KftGlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine. | Biological | HB Tritanrix-HepB/Hiberix Kft. Mix Group, PRP Tritanrix-HepB Kft. Mix Group, Tritanrix-HepB/Hiberix Kft. Mix Group, Tritanrix-HepB/Hiberix Kft. Ref Group |
| Tritanrix™-HepB/Hiberix™Also: DTPw-HBV/HibGSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine | Biological | PRP Tritanrix-HepB Kft. Ref Group, Tritanrix-HepB/Hiberix Kft. Ref Group |
| Hiberix™GSK Biologicals' Haemophilus influenzae type b vaccine | Biological | Tritanrix-HepB Kft.+Hiberix Group |
| Polyribosil-Ribitol-Phosphate (PRP) vaccineplain PRP polysaccharide vaccine | Biological | PRP Tritanrix-HepB Kft. Mix Group, PRP Tritanrix-HepB Kft. Ref Group |
| Tritanrix™-HepB KftAlso: DTPw-HBV KftGSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary. | Biological | PRP Tritanrix-HepB Kft. Mix Group, PRP Tritanrix-HepB Kft. Ref Group, Tritanrix-HepB Kft.+Hiberix Group |
Primary outcome
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Time frame: At Month 1, post-PRP challenge
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Time frame: At Month 1, post-booster vaccination
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Time frame: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).
Seroprotection Rates for Anti-D Antibodies
Time frame: At Month 1, post-booster vaccination
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Time frame: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
Time frame: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).
Number of Subjects With Booster Response to BPT Antigen
Time frame: At Month 1, post-booster vaccination
The booster response was defined as: * an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or * at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.
Anti-PRP Antibody Concentrations
Time frame: At Month 1, post-PRP challenge
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-PRP Antibody Concentrations.
Time frame: At Month 1, post-booster vaccination
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-D and Anti-T Antibody Concentrations
Time frame: At Month 1, post-booster vaccination
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Anti-HBs Antibody Concentrations
Time frame: At Month 1, post-booster vaccination
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Anti-BPT Antibody Concentrations
Time frame: At Month 1, post-booster vaccination
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
17 secondary outcomes
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Time frame: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Time frame: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Time frame: At Month 0, prior to the PRP challenge
Seroprotection Rates for Anti-D Antibodies
Time frame: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value
Time frame: At Month 0, prior to the PRP challenge
Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value
Time frame: At Month 0, prior to the PRP challenge
Anti- PRP Antibody Concentrations
Time frame: At Month 0, prior to the PRP challenge
Anti- PRP Antibody Concentrations.
Time frame: At Month 0, prior to the PRP challenge
Anti-D and Anti-T Antibody Concentrations.
Time frame: At Month 0, prior to the PRP challenge
Anti-HBs Antibody Concentrations.
Time frame: At Month 0, prior to the PRP challenge
Anti-BPT Antibody Concentrations.
Time frame: At Month 0, prior to the PRP challenge
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-Day (Days 0-3) post-PRP challenge
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-Day (Days 0-3) post-PRP challenge
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 4-Day (Days 0-3) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 4-Day (Days 0-3) post-booster vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-Day (Day 0-30) follow-up period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 to Month 9.5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundGatchalian et al. A new DTPw-HBV/Hib vaccine: Immunogenic and safe for primary vaccination and booster dosing in the second year of life - 5th World Congress WSPID, Bangkok, Thailand, 15-18 Nov 2007
- Background: PubMed 18376148Gatchalian S, Reyes M, Bermal N, Chandrasekaran V, Han HH, Bock HL, Lefevre I. A new DTPw-HBV/Hib vaccine: immune memory after primary vaccination and booster dosing in the second year of life. Hum Vaccin. 2008 Jan-Feb;4(1):60-6. doi: 10.4161/hv.4.1.5069. Epub 2007 Sep 23.
- 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.
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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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 Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™ and Hiberix™ in people with Whole Cell Pertussis and Diphtheria, run by GlaxoSmithKline at 3 sites 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 7 inclusion and 3 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 6 Jun 2018. 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 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 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 28 Feb 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 Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL (time frame: At Month 1, post-PRP challenge). The study lists 12 primary outcomes in all. 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 NCT00169442, which also lists 2 linked publications.
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 6 Jun 2018.