Infections, MeningococcalPhase 3NCT00614614
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
A Phase 3 study testing GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) and Infanrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 56 sites in United States.
Trial summary
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) and Infanrix®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,558 participants
- Where
- 56 sitesUnited States
- Study dates
- 13 Feb 2008to 17 Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after 36 weeks gestation.
- For inclusion in the booster phase, subjects must have received all three doses in the primary phase.
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 study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
- 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 vaccines, or by dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), 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 entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
- Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
- Previous administration of a booster dose of Hib prior to entry to the booster phase.
- Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
- Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
- Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
- History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
GSK Investigational Site
Amarillo, Texas, 79124
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Benton, Arkansas, 72019
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Alabama, 35244
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02130
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Clyde, North Carolina, 28721
GSK Investigational Site
Des Moines, Iowa, 50312
GSK Investigational Site
Dothan, Alabama, 36305
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fall River, Massachusetts, 02724
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Galveston, Texas, 77555-1119
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Henderson, Nevada, 89015
GSK Investigational Site
Huber Heights, Ohio, 45424
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kalamazoo, Michigan, 49008
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Nampa, Idaho, 208 463 3126
GSK Investigational Site
Niles, Michigan, 49120
GSK Investigational Site
Ogden, Utah, 84405
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Pittsburgh, Pennsylvania, 15220
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plantation, Florida, 33324
GSK Investigational Site
Portage, Michigan, 49024
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Richland, Michigan, 49083
GSK Investigational Site
Roy, Utah, 84067
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
West Des Moines, Iowa, 50266
GSK Investigational Site
West Palm Beach, Florida, 33407
GSK Investigational Site
Woodstock, Georgia, 30189
About this study
Official title: Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Read the detailed description
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.
Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.
The protocol posting has been updated following a protocol amendment.
- Conditions
- Infections, Meningococcal
- Being tested
- GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix), Infanrix®, ActHIB®, Pediarix®
- Keywords
- Meningococcal disease, Toddlers, Neisseria meningitidis, Meningococcal vaccines, Immunogenicity, Human serum bactericidal assay, Safety, Vaccines, conjugate, Booster vaccination
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)Biological
Also called Nimenrix
One dose in the booster phase as intramuscular injection
GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)Biological
Also called Menhibrix
Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
Infanrix®Biological
One dose as intramuscular injection
ActHIB®Biological
Three doses in the priming phase as intramuscular injection
Pediarix®Biological
Three doses in the priming phase as intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Menhibrix 1 Group | Experimental | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group]. Receives: Biological: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix); Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix); Biological: Infanrix®; Biological: Pediarix® |
| ActHIB- Infanrix Group | Active comparator | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age. Receives: Biological: Infanrix®; Biological: ActHIB®; Biological: Pediarix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Measured: One month post vaccination at 12-15 months of age (Month 11)
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Measured: One month post vaccination at 15-18 months of age (Month 14)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: One month post vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: One month post vaccination at 15-18 months of age (Month 14)
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Measured: One month post vaccination at 15-18 months of age (Month 14)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: One month post vaccination at 12-15 months of age (Month 11)
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Measured: One month post vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Measured: One month after vaccination at 15-18 months of age (Month 14)
Secondary outcomes (22)
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4
Measured: One month after vaccination at 12-15 months of age (Month 11)
Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4
Measured: One month after vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: One month after vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: Prior to vaccination at 15-18 months of age (Month 13)
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8
Measured: Prior to vaccination at 15-18 months of age (Month 13)
Anti-D and Anti-T Geometric Mean Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).
Measured: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
Measured: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Measured: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Measured: One month after vaccination at 15-18 months of age (Month 14)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Measured: One month after vaccination at 15-18 months of age (Month 14)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4
Measured: One month after vaccination at 15-18 months of age (Month 14)
Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Measured: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Measured: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination
Number of Subjects Reporting Any Rash
Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Measured: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: During a 31-day follow-up period (Day 0-30)
Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: During the 31-day follow-up period (Day 0-30)
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study start13 Feb 2008
- Primary completion31 Jul 2009
- Study completion17 Sep 2009
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 Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,558 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
- NCT00614614
- Sponsor's protocol ID
- 110870
- Other IDs
- 110871
- Status last verified
- Oct 2016
- First submitted
- 31 Jan 2008
- Last updated
- 21 Sep 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
Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8.
PubMed 25305567Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.
PubMed 25152325
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
- ClinicalTrials.gov ID
- NCT00614614
- Acronym / sponsor ID
- 110870
- Conditions
- Infections, Meningococcal
- Keywords
- Meningococcal disease, Toddlers, Neisseria meningitidis, Meningococcal vaccines, Immunogenicity, Human serum bactericidal assay, Safety, Vaccines, conjugate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,558 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2008
- Primary completion
- 31 Jul 2009 (actual)
- Study completion
- 17 Sep 2009 (actual)
- First posted
- 13 Feb 2008 (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.
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Detailed description
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.
Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.
The protocol posting has been updated following a protocol amendment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menhibrix 1 Group | Experimental | Biological: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix), Biological: Infanrix®, Biological: Pediarix®Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group]. |
| ActHIB- Infanrix Group | Active comparator | Biological: Infanrix®, Biological: ActHIB®, Biological: Pediarix®Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after 36 weeks gestation.
Key exclusion criteria (28 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 study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
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 |
|---|---|---|
| GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)Also: NimenrixOne dose in the booster phase as intramuscular injection | Biological | Menhibrix 1 Group |
| GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)Also: MenhibrixThree doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection | Biological | Menhibrix 1 Group |
| Infanrix®One dose as intramuscular injection | Biological | ActHIB- Infanrix Group, Menhibrix 1 Group |
| ActHIB®Three doses in the priming phase as intramuscular injection | Biological | ActHIB- Infanrix Group |
| Pediarix®Three doses in the priming phase as intramuscular injection | Biological | ActHIB- Infanrix Group, Menhibrix 1 Group |
Primary outcome
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
Time frame: One month post vaccination at 12-15 months of age (Month 11)
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
Time frame: One month post vaccination at 15-18 months of age (Month 14)
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Antibody titers were expressed as Geometric mean titers (GMTs)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Time frame: One month post vaccination at 15-18 months of age (Month 14)
Antibody titers were expressed as Geometric mean titers (GMTs)
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
Time frame: One month post vaccination at 15-18 months of age (Month 14)
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Antibody titers were expressed as Geometric mean titers (GMTs)
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
Time frame: One month post vaccination at 12-15 months of age (Month 11)
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
22 secondary outcomes
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Time frame: Prior to vaccination at 15-18 months of age (Month 13)
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
Time frame: Prior to vaccination at 15-18 months of age (Month 13)
Anti-D and Anti-T Geometric Mean Antibody Concentrations
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Time frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Time frame: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination
Number of Subjects Reporting Any Rash
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Time frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Time frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination
Time frame: During a 31-day follow-up period (Day 0-30)
Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination
Time frame: During the 31-day follow-up period (Day 0-30)
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25305567Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8.
- Derived from this study: PubMed 25152325Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.
- 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
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) and Infanrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 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 Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group (time frame: One month post vaccination at 12-15 months of age (Month 11)). The study lists 8 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 NCT00614614, 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 21 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.