Whole Cell PertussisPhase 3NCT00136604
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
A Phase 3 study testing Tritanrix-HepB/Hib-MenAC, Mencevax ACWY and Tritanrix-HepB/Hiberix in people with Whole Cell Pertussis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in Thailand.
Trial summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Read more about this study
- Who is it for?
- Ages 427 to 730 daysHealthy volunteers can take part
- Conditions the study is for
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B
- What is being tested?
- Tritanrix-HepB/Hib-MenAC, Mencevax ACWY 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
- 617 participants
- Where
- 3 sitesThailand
- Study dates
- 22 Jan 2006to 23 Apr 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 427 to 730 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female between and including 15 and 24 months of age
- Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
Who cannot join
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
- History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Songkhla, 90110
About this study
Official title: Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Read the detailed description
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria, Tetanus, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
- Being tested
- Tritanrix-HepB/Hib-MenAC, Mencevax ACWY, Tritanrix-HepB/Hiberix, Meningitec
- Keywords
- Prophylaxis diphtheria, Hib & meningococcal serogroup A & C disease
- Medical subject headings
- Haemophilus Infections, Hepatitis B, Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanrix-HepB/Hib-MenACBiological
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
Mencevax ACWYBiological
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
Tritanrix-HepB/HiberixBiological
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
MeningitecBiological
Wyeth's MenC CRM197 conjugated vaccine, Meningitec
| Study group | Role | What they receive |
|---|---|---|
| ACAC GROUP | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. Receives: Biological: Tritanrix-HepB/Hib-MenAC |
| ACHibPS GROUP | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm Receives: Biological: Mencevax ACWY; Biological: Tritanrix-HepB/Hiberix |
| HibACPS GROUP | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm Receives: Biological: Tritanrix-HepB/Hib-MenAC; Biological: Mencevax ACWY |
| HibHibPS GROUP | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. Receives: Biological: Mencevax ACWY; Biological: Tritanrix-HepB/Hiberix |
| CC GROUP | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. Receives: Biological: Tritanrix-HepB/Hiberix; Biological: Meningitec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Measured: One month Post-Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Measured: One Month Post-Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Measured: One Month Post-Booster vaccination at 15-24 months of age
Secondary outcomes (22)
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-SBA-MenC Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-rSBA-MenA Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSC Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSA Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA.
Measured: One month after (POST) the Booster vaccination at 15-24 months of age
Anti-D Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-TT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).
Measured: One month Post-Booster vaccination
Anti-BPT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Day 0 to Day 3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period
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 (Days 0-30) post-vaccination period
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: Up to one month Post-Booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study start22 Jan 2006
- Primary completion23 Apr 2006
- Study completion23 Apr 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.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 617 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
- NCT00136604
- Sponsor's protocol ID
- 104727 (Booster - 15-24 mths)
- Other IDs
- 104730
- Status last verified
- Feb 2020
- First submitted
- 26 Aug 2005
- Last updated
- 20 Feb 2020
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC
- ClinicalTrials.gov ID
- NCT00136604
- Acronym / sponsor ID
- 104727 (Booster - 15-24 mths)
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria, Tetanus, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
- Keywords
- Prophylaxis diphtheria, Hib & meningococcal serogroup A & C disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2006 (actual)
- Primary completion
- 23 Apr 2006 (actual)
- Study completion
- 23 Apr 2006 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Posted 17 Sep 2018
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 the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Detailed description
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ACAC GROUP | Experimental | Biological: Tritanrix-HepB/Hib-MenACSubjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. |
| ACHibPS GROUP | Experimental | Biological: Mencevax ACWY, Biological: Tritanrix-HepB/HiberixSubjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibACPS GROUP | Experimental | Biological: Tritanrix-HepB/Hib-MenAC, Biological: Mencevax ACWYSubjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibHibPS GROUP | Experimental | Biological: Mencevax ACWY, Biological: Tritanrix-HepB/HiberixSubjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| CC GROUP | Experimental | Biological: Tritanrix-HepB/Hiberix, Biological: MeningitecSubjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. |
Who may qualify
- Ages
- 427 to 730 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy male or female between and including 15 and 24 months of age
- Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
Key exclusion criteria (6 listed)
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
- History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
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/Hib-MenACCombined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine | Biological | ACAC GROUP, HibACPS GROUP |
| Mencevax ACWYGSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine | Biological | ACHibPS GROUP, HibACPS GROUP, HibHibPS GROUP |
| Tritanrix-HepB/HiberixCombined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine | Biological | ACHibPS GROUP, CC GROUP, HibHibPS GROUP |
| MeningitecWyeth's MenC CRM197 conjugated vaccine, Meningitec | Biological | CC GROUP |
Primary outcome
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
Time frame: One month Post-Booster vaccination at 15-24 months of age
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
22 secondary outcomes
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PRP Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-SBA-MenC Antibody Titers
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-rSBA-MenA Antibody Titers
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSC Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PSA Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
Time frame: One month after (POST) the Booster vaccination at 15-24 months of age
Anti-D Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-TT Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
Time frame: One month Post-Booster vaccination
Anti-BPT Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-HBs Antibody Concentrations
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Day 0 to Day 3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Up to one month Post-Booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Primary StudyLink 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
Not yet recruitingPhase 1/2
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)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 2/3
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/Hib-MenAC, Mencevax ACWY and Tritanrix-HepB/Hiberix in people with Whole Cell Pertussis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in Thailand.
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 2 inclusion and 6 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 20 Feb 2020. 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 Thailand. 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 17 Sep 2018). 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?
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value (time frame: One month Post-Booster vaccination at 15-24 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2020.