Neisseria MeningitidisPhase 2NCT00134719
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
A Phase 2 study testing MenHibrix (Hib-MenCY-TT), Infanrix® Penta and Prevenar® in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in Australia.
Trial summary
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 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
- Neisseria Meningitidis, Haemophilus Influenzae Type b
- What is being tested?
- MenHibrix (Hib-MenCY-TT), Infanrix® Penta and Prevenar®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 3 sitesAustralia
- Study dates
- 11 Apr 2005to 21 Feb 2007
- 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
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period between 36 and 42 weeks.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Additional specific criteria for the booster part of the study
- History of or previous vaccination against measles, mumps, rubella or varicella.
- Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Perth, Western Australia
About this study
Official title: A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Read the detailed description
The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.
- Being tested
- MenHibrix (Hib-MenCY-TT), Infanrix® Penta, Prevenar®, ActHIB®, Meningitec®
- Keywords
- Invasive Hib & N. meningitidis diseases
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenHibrix (Hib-MenCY-TT)Biological
One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)
Infanrix® PentaBiological
One intramuscular dose at 2, 4 and 6 months of age
Prevenar®Biological
One intramuscular dose at 2, 4 and 6 months of age
ActHIB®Biological
One intramuscular dose at 2, 4 and 6 months of age
Meningitec®Biological
One intramuscular dose at 2, 4 and 6 months of age
M-M-R®IIBiological
One subcutaneous dose at 12-15 months of age
Varivax®Biological
One subcutaneous dose at 12 to 15 months of age
PedvaxHIB®Biological
One intramuscular dose at 12 to 15 months of age
| Study group | Role | What they receive |
|---|---|---|
| MenHibrix Group | Experimental | Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. Receives: Biological: MenHibrix (Hib-MenCY-TT); Biological: Infanrix® Penta; Biological: Prevenar®; Biological: M-M-R®II; Biological: Varivax® |
| ActHIB + Meningitec Group | Active comparator | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. Receives: Biological: MenHibrix (Hib-MenCY-TT); Biological: Infanrix® Penta; Biological: Prevenar®; Biological: ActHIB®; Biological: Meningitec®; Biological: M-M-R®II; Biological: Varivax® |
| ActHIB/PedvaxHIB Group | Active comparator | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. Receives: Biological: Infanrix® Penta; Biological: Prevenar®; Biological: ActHIB®; Biological: M-M-R®II; Biological: Varivax®; Biological: PedvaxHIB® |
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) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Measured: One month after the 3-dose primary vaccination course
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Measured: One month after the 3-dose primary vaccination course
Number of Subjects Seroconverted for Anti-measles Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
Measured: 42 days after the fourth dose vaccination
Number of Subjects Seroconverted for Anti-mumps Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Measured: 42 days after the fourth dose vaccination
Number of Subjects With an Anti-rubella Seroresponse
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
Measured: 42 days after the fourth dose vaccination
Number of Subjects Seroconverted for Anti-varicella Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
Measured: 42 days after the fourth dose vaccination
Secondary outcomes (35)
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
rSBA-MenC Titers
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
rSBA-MenY Titers
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
hSBA-MenC Titers
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
hSBA-MenY Titers
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PSC Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PSY Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PRP Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Measured: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL
The cut-off value assessed was 150 mIU/mL.
Measured: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Measured: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL
The cut-off value assessed was 4 IU/mL.
Measured: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5
The cut-off value assessed was a titer of 1:5.
Measured: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With a Fourth Dose Response for hSBA-MenC
Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.
Measured: 42 days after the fourth dose
Number of Subjects With a Fourth Dose Response for hSBA-MenY
Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Measured: 42 days after the fourth dose
Anti-measles Concentrations in Initially Seronegative Subjects
Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.
Measured: 42 days after the fourth dose
Anti-rubella Concentrations in Initially Seronegative Subjects
Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Measured: 42 days after the fourth dose
Anti-mumps Titers in Initially Seronegative Subjects
Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Measured: 42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Measured: 42 days after the fourth dose
Anti-varicella Titers in Initially Seronegative Subjects
Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Measured: 42 days after the fourth dose
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Measured: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Measured: During a 4-day period (Day 0-3) after the fourth dose vaccination phase
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event covers any adverse event 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) post-primary and post-fourth dose vaccination period
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine
Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.
Measured: During a 43-day (Day 0-42) after the fourth dose
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Measured: From enrolment through the day preceding the fourth dose
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Measured: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study start11 Apr 2005
- Primary completion24 Jul 2006
- Study completion21 Feb 2007
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 (3)Papers the sponsor has linked to this study.
- Other trials for Neisseria MeningitidisStudies 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
- None (open label)
- Enrolment
- 1,104 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
- NCT00134719
- Sponsor's protocol ID
- 102370 (primary study)
- Other IDs
- 102371
- Status last verified
- May 2018
- First submitted
- 10 Aug 2005
- Last updated
- 19 Jul 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 21806393Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
PubMed 22617844Nolan T, Richmond P, Marshall H, McVernon J, Alexander K, Mesaros N, Aris E, Miller J, Poolman J, Boutriau D. Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011 Mar;30(3):190-6. doi: 10.1097/INF.0b013e3181fcb2bf.
PubMed 20948453
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months
- ClinicalTrials.gov ID
- NCT00134719
- Acronym / sponsor ID
- 102370 (primary study)
- Keywords
- Invasive Hib & N. meningitidis diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2005 (actual)
- Primary completion
- 24 Jul 2006 (actual)
- Study completion
- 21 Feb 2007 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Posted 20 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 is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Detailed description
The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MenHibrix Group | Experimental | Biological: MenHibrix (Hib-MenCY-TT), Biological: Infanrix® Penta, Biological: Prevenar®, Biological: M-M-R®II, Biological: Varivax®Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| ActHIB + Meningitec Group | Active comparator | Biological: MenHibrix (Hib-MenCY-TT), Biological: Infanrix® Penta, Biological: Prevenar®, Biological: ActHIB®, Biological: Meningitec®, Biological: M-M-R®II, Biological: Varivax®Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| ActHIB/PedvaxHIB Group | Active comparator | Biological: Infanrix® Penta, Biological: Prevenar®, Biological: ActHIB®, Biological: M-M-R®II, Biological: Varivax®, Biological: PedvaxHIB®Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period between 36 and 42 weeks.
Key exclusion criteria (14 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
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 |
|---|---|---|
| MenHibrix (Hib-MenCY-TT)One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B) | Biological | ActHIB + Meningitec Group, MenHibrix Group |
| Infanrix® PentaOne intramuscular dose at 2, 4 and 6 months of age | Biological | ActHIB + Meningitec Group, ActHIB/PedvaxHIB Group, MenHibrix Group |
| Prevenar®One intramuscular dose at 2, 4 and 6 months of age | Biological | ActHIB + Meningitec Group, ActHIB/PedvaxHIB Group, MenHibrix Group |
| ActHIB®One intramuscular dose at 2, 4 and 6 months of age | Biological | ActHIB + Meningitec Group, ActHIB/PedvaxHIB Group |
| Meningitec®One intramuscular dose at 2, 4 and 6 months of age | Biological | ActHIB + Meningitec Group |
| M-M-R®IIOne subcutaneous dose at 12-15 months of age | Biological | ActHIB + Meningitec Group, ActHIB/PedvaxHIB Group, MenHibrix Group |
| Varivax®One subcutaneous dose at 12 to 15 months of age | Biological | ActHIB + Meningitec Group, ActHIB/PedvaxHIB Group, MenHibrix Group |
| PedvaxHIB®One intramuscular dose at 12 to 15 months of age | Biological | ActHIB/PedvaxHIB Group |
Primary outcome
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)
Time frame: One month after the 3-dose primary vaccination course
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128
Time frame: One month after the 3-dose primary vaccination course
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Number of Subjects Seroconverted for Anti-measles Antibodies
Time frame: 42 days after the fourth dose vaccination
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
Number of Subjects Seroconverted for Anti-mumps Antibodies
Time frame: 42 days after the fourth dose vaccination
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Number of Subjects With an Anti-rubella Seroresponse
Time frame: 42 days after the fourth dose vaccination
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
Number of Subjects Seroconverted for Anti-varicella Antibodies
Time frame: 42 days after the fourth dose vaccination
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
35 secondary outcomes
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
rSBA-MenC Titers
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
rSBA-MenY Titers
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
hSBA-MenC Titers
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
hSBA-MenY Titers
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PSC Concentrations
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PSY Concentrations
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Anti-PRP Concentrations
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Number of Subjects With a Fourth Dose Response for hSBA-MenC
Time frame: 42 days after the fourth dose
Number of Subjects With a Fourth Dose Response for hSBA-MenY
Time frame: 42 days after the fourth dose
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Anti-measles Concentrations in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Anti-rubella Concentrations in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination
Time frame: 42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Anti-mumps Titers in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Anti-varicella Titers in Initially Seronegative Subjects
Time frame: 42 days after the fourth dose
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase
Time frame: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase
Time frame: During a 4-day period (Day 0-3) after the fourth dose vaccination phase
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine
Time frame: During a 43-day (Day 0-42) after the fourth dose
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase
Time frame: From enrolment through the day preceding the fourth dose
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase
Time frame: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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 22617844Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
- Background: PubMed 20948453Nolan T, Richmond P, Marshall H, McVernon J, Alexander K, Mesaros N, Aris E, Miller J, Poolman J, Boutriau D. Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011 Mar;30(3):190-6. doi: 10.1097/INF.0b013e3181fcb2bf.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenHibrix (Hib-MenCY-TT), Infanrix® Penta and Prevenar® in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 3 sites in Australia.
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 5 inclusion and 14 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 19 Jul 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 Australia. 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 20 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) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) (time frame: One month after the 3-dose primary vaccination course). 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 NCT00134719, which also lists 3 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 19 Jul 2018.