Infections, MeningococcalPhase 3NCT00474266
Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
A Phase 3 study testing Meningococcal vaccine GSK134612 (Nimenrix), Priorix-Tetra and Meningitec in people with Infections, Meningococcal, run by GlaxoSmithKline at 14 sites in Finland.
Trial summary
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612 (Nimenrix), Priorix-Tetra and Meningitec
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 14 sitesFinland
- Study dates
- 5 Jun 2007to 26 Mar 2008
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the 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.
- Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.
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 within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
- Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- History of meningococcal disease.
- Previous vaccination against measles, mumps, rubella, and/or varicella.
Show all 13Show fewer
- History of measles, mumps, rubella and/or varicella.
- Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Finland14 sites
GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kotka, 48600
GSK Investigational Site
Kuopio, 70100
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
GSK Investigational Site
Vantaa, 01600
About this study
Official title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.
For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612 (Nimenrix), Priorix-Tetra, Meningitec
- Keywords
- MMRV vaccine, co-administration, immunogenicity, meningococcal vaccine, conjugate vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612 (Nimenrix)Biological
Single dose intramuscular injection
Priorix-TetraBiological
2-dose subcutaneous injection
MeningitecBiological
Single dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix + Priorix-Tetra Group | Experimental | Subjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84. Receives: Biological: Meningococcal vaccine GSK134612 (Nimenrix); Biological: Priorix-Tetra |
| Nimenrix Group | Experimental | Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later. Receives: Biological: Meningococcal vaccine GSK134612 (Nimenrix); Biological: Priorix-Tetra |
| Priorix-Tetra Group | Active comparator | Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84. Receives: Biological: Priorix-Tetra; Biological: Meningitec |
| Meningitec Group | Active comparator | Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later. Receives: Biological: Priorix-Tetra; Biological: Meningitec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Measured: 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
Measured: 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
Measured: 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
Measured: 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.
Measured: 42 days after the first vaccine dose (Day 42)
Secondary outcomes (22)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Measured: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Measured: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Measured: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Measured: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Measured: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Measured: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.
Measured: 42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
Measured: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-mumps Antibody Concentrations
Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.
Measured: 42 days after the first vaccine dose (Day 42)
Anti-mumps Antibody Concentrations
Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
Measured: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-rubella Antibody Concentrations
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.
Measured: 42 days after the first vaccine dose (Day 42)
Anti-rubella Antibody Concentrations
Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
Measured: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-varicella Antibody Titers
Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.
Measured: 42 days after the first vaccine dose (Day 42)
Anti-varicella Antibody Titers
Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.
Measured: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
Measured: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0
Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.
Measured: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.
Measured: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms
Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.
Measured: During the 43-day (Days 0-42) after first vaccination dose
Number of Subjects Reporting Specific Adverse Events (AEs)
Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.
Measured: From Day 0 up to Month 6 after first vaccine dose
Number of Subjects Reporting Unsolicited Symptoms
Unsolicited symptom covers any symptom 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 43-day (Days 0-42) post Dose 1 vaccination period
Number of Subjects Reporting Unsolicited Symptoms
Unsolicited symptom covers any symptom 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 43-day (Days 0-42) follow-up period after each vaccination
Number of Subjects Reporting 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.
Measured: From Day 0 up to Month 6 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study start5 Jun 2007
- Primary completion26 Feb 2008
- Study completion26 Mar 2008
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
- None (open label)
- Enrolment
- 1,000 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
- NCT00474266
- Sponsor's protocol ID
- 109670
- Other IDs
- 2006-006580-23
- Status last verified
- Nov 2019
- First submitted
- 15 May 2007
- Last updated
- 18 Nov 2019
- 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
Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.
PubMed 21443965Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
PubMed 26780033
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
- ClinicalTrials.gov ID
- NCT00474266
- Acronym / sponsor ID
- 109670
- Conditions
- Infections, Meningococcal
- Keywords
- MMRV vaccine, co-administration, immunogenicity, meningococcal vaccine, conjugate vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2007 (actual)
- Primary completion
- 26 Feb 2008 (actual)
- Study completion
- 26 Mar 2008 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Posted 15 Dec 2017
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 this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.
For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nimenrix + Priorix-Tetra Group | Experimental | Biological: Meningococcal vaccine GSK134612 (Nimenrix), Biological: Priorix-TetraSubjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84. |
| Nimenrix Group | Experimental | Biological: Meningococcal vaccine GSK134612 (Nimenrix), Biological: Priorix-TetraSubjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later. |
| Priorix-Tetra Group | Active comparator | Biological: Priorix-Tetra, Biological: MeningitecSubjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84. |
| Meningitec Group | Active comparator | Biological: Priorix-Tetra, Biological: MeningitecSubjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later. |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the 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.
- Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.
Key exclusion criteria (13 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 within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
- Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- History of meningococcal 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 |
|---|---|---|
| Meningococcal vaccine GSK134612 (Nimenrix)Single dose intramuscular injection | Biological | Nimenrix + Priorix-Tetra Group, Nimenrix Group |
| Priorix-Tetra2-dose subcutaneous injection | Biological | Meningitec Group, Nimenrix + Priorix-Tetra Group, Nimenrix Group, Priorix-Tetra Group |
| MeningitecSingle dose intramuscular injection | Biological | Meningitec Group, Priorix-Tetra Group |
Primary outcome
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
Time frame: 42 days after the first vaccine dose (Day 42)
The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
Time frame: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
Time frame: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
Time frame: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
Time frame: 42 days after the first vaccine dose (Day 42)
The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.
22 secondary outcomes
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
Time frame: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
Time frame: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Time frame: 42 days after the first vaccine dose (Day 42)
Anti-measles Antibody Concentrations
Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-mumps Antibody Concentrations
Time frame: 42 days after the first vaccine dose (Day 42)
Anti-mumps Antibody Concentrations
Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-rubella Antibody Concentrations
Time frame: 42 days after the first vaccine dose (Day 42)
Anti-rubella Antibody Concentrations
Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-varicella Antibody Titers
Time frame: 42 days after the first vaccine dose (Day 42)
Anti-varicella Antibody Titers
Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination
Time frame: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0
Time frame: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms
Time frame: During the 43-day (Days 0-42) after first vaccination dose
Number of Subjects Reporting Specific Adverse Events (AEs)
Time frame: From Day 0 up to Month 6 after first vaccine dose
Number of Subjects Reporting Unsolicited Symptoms
Time frame: During the 43-day (Days 0-42) post Dose 1 vaccination period
Number of Subjects Reporting Unsolicited Symptoms
Time frame: During the 43-day (Days 0-42) follow-up period after each vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From Day 0 up to Month 6 after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21443965Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.
- Background: PubMed 26780033Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
- 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
14 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 Meningococcal vaccine GSK134612 (Nimenrix), Priorix-Tetra and Meningitec in people with Infections, Meningococcal, run by GlaxoSmithKline at 14 sites in Finland.
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 13 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Finland. 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 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values (time frame: 42 days after the first vaccine dose (Day 42)). The study lists 5 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 NCT00474266, 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 18 Nov 2019.