Haemophilus Influenzae Type bPhase 2NCT00129116
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
A Phase 2 study testing Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine and Menjugate ® in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 26 sites in 2 countries.
Trial summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b, Neisseria Meningitidis
- What is being tested?
- Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine and Menjugate ®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 1 Mar 2003to 16 Dec 2003
- Phase
- Phase 2
- 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Who cannot join
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
Germany19 sites
GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 13355
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Cham, Bavaria, 93413
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Hamburg, 22307
GSK Investigational Site
Kaufering, Bavaria, 86916
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Munich, Bavaria, 80939
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Niedernhausen, Hesse, 65527
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Olching, Bavaria, 82140
Belgium7 sites
GSK Investigational Site
Asse, 1730
GSK Investigational Site
Drongen, 9031
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Maldegem, 9990
GSK Investigational Site
Merelbeke, 9820
GSK Investigational Site
Oudenaarde, 9700
GSK Investigational Site
Sint-Amandsberg, 9040
About this study
Official title: A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Read the detailed description
Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \& one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
- Being tested
- Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine, Menjugate ®, Infanrix penta ®, Infanrix hexa ®
- Keywords
- Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib-MenCY-TT vaccineBiological
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Hib-MenC-TT vaccineBiological
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Menjugate ®Biological
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Infanrix penta ®Biological
Also called DTPa-HBV-IPV vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Infanrix hexa ®Biological
Also called DTPa-HBV-IPV/Hib vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
| Study group | Role | What they receive |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Experimental | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. Receives: Biological: Hib-MenCY-TT vaccine; Biological: Infanrix penta ® |
| Menhibrix F2/Infanrix-penta Group | Experimental | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. Receives: Biological: Hib-MenCY-TT vaccine; Biological: Infanrix penta ® |
| Menhibrix F3/Infanrix-penta Group | Experimental | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. Receives: Biological: Hib-MenCY-TT vaccine; Biological: Infanrix penta ® |
| Menitorix/Infanrix-penta Group | Experimental | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. Receives: Biological: Hib-MenC-TT vaccine; Biological: Infanrix penta ® |
| Menjugate/Infanrix-hexa Group | Active comparator | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. Receives: Biological: Menjugate ®; Biological: Infanrix hexa ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Measured: One month after dose 3 (at study Month 3 - primary phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Measured: One month after dose 3 (at study Month 3 - primary phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Measured: One month after dose 3 (at study Month 3 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Measured: One month after the booster vaccination (at study Month 1 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Measured: One month after the booster vaccination (at study Month 1 - booster phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Measured: One month after the booster vaccination (at study Month 1 - booster phase)
Secondary outcomes (45)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Measured: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Measured: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Measured: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Measured: Prior to the booster vaccination (at study Month 0 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Measured: Prior to the booster vaccination (at study Month 0 - booster phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Measured: Prior to the booster vaccination (at study Month 0 - booster phase)
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-tetanus Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
Measured: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-T Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Measured: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-diphtheria Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Measured: One month after the third dose (at study Month 3 - primary phase)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
Measured: One month after the third dose (at study Month 3 - primary phase)
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Measured: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Measured: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Measured: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
Measured: One month after the third dose (at study Month 3 - primary phase)
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Measured: One month after the third dose (at study Month 3 - primary phase)
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Measured: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Measured: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Measured: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: Over the full course of the primary phase (up to study Month 3 - primary phase)
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Measured: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Measured: During the 8-day (Day 0-7) follow-up period (during the booster phase)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Measured: During the 31-day (Day 0-30) follow-up period (during the booster phase)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: Over the full course of the booster phase (up to study Month 1 - booster phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study start1 Mar 2003
- Primary completion1 Dec 2003
- Study completion16 Dec 2003
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 Haemophilus Influenzae Type bStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 388 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
- NCT00129116
- Sponsor's protocol ID
- 792014/003
- Other IDs
- 100381
- Status last verified
- Oct 2016
- First submitted
- 10 Aug 2005
- Last updated
- 27 Aug 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
Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
PubMed 21806393Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51. doi: 10.4161/hv.6.8.12154.
PubMed 20697200
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
- ClinicalTrials.gov ID
- NCT00129116
- Acronym / sponsor ID
- 792014/003
- Keywords
- Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2003
- Primary completion
- 1 Dec 2003 (actual)
- Study completion
- 16 Dec 2003 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 23 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Detailed description
Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \& one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Menhibrix F1/Infanrix-penta Group | Experimental | Biological: Hib-MenCY-TT vaccine, Biological: Infanrix penta ®Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F2/Infanrix-penta Group | Experimental | Biological: Hib-MenCY-TT vaccine, Biological: Infanrix penta ®Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F3/Infanrix-penta Group | Experimental | Biological: Hib-MenCY-TT vaccine, Biological: Infanrix penta ®Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menitorix/Infanrix-penta Group | Experimental | Biological: Hib-MenC-TT vaccine, Biological: Infanrix penta ®Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menjugate/Infanrix-hexa Group | Active comparator | Biological: Menjugate ®, Biological: Infanrix hexa ®Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Key exclusion criteria (1 listed)
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
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 |
|---|---|---|
| Hib-MenCY-TT vaccineThree doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. | Biological | Menhibrix F1/Infanrix-penta Group, Menhibrix F2/Infanrix-penta Group, Menhibrix F3/Infanrix-penta Group |
| Hib-MenC-TT vaccineThree doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. | Biological | Menitorix/Infanrix-penta Group |
| Menjugate ®Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. | Biological | Menjugate/Infanrix-hexa Group |
| Infanrix penta ®Also: DTPa-HBV-IPV vaccineThree doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. | Biological | Menhibrix F1/Infanrix-penta Group, Menhibrix F2/Infanrix-penta Group, Menhibrix F3/Infanrix-penta Group, Menitorix/Infanrix-penta Group |
| Infanrix hexa ®Also: DTPa-HBV-IPV/Hib vaccineThree doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. | Biological | Menjugate/Infanrix-hexa Group |
Primary outcome
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Time frame: One month after dose 3 (at study Month 3 - primary phase)
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Time frame: One month after dose 3 (at study Month 3 - primary phase)
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Time frame: One month after dose 3 (at study Month 3 - primary phase)
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
45 secondary outcomes
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
rSBA-MenC Antibody Titres
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
rSBA-MenY Antibody Titres
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PRP Antibody Concentrations
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSC Antibody Concentrations
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSY Antibody Concentrations
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-tetanus Antibody Concentrations
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PRP Antibody Concentrations
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenC Antibody Titres
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenY Antibody Titres
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSC Antibody Concentrations
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSY Antibody Concentrations
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-T Antibody Concentrations
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-diphtheria Antibody Concentrations
Time frame: One month after the third dose (at study Month 3 - primary phase)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Time frame: One month after the third dose (at study Month 3 - primary phase)
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Subjects With Vaccine Response to PT, FHA and PRN
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Subjects With Solicited Local Symptoms
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Number of Subjects With Solicited General Symptoms
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-30) follow-up period (during the primary phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21806393Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
- Background: PubMed 20697200Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51. doi: 10.4161/hv.6.8.12154.
- 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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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
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine and Menjugate ® in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 26 sites in 2 countries.
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 1 inclusion and 1 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2012). 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-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). (time frame: One month after dose 3 (at study Month 3 - primary phase)). The study lists 6 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 NCT00129116, 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 27 Aug 2018.