Infections, MeningococcalPhase 3NCT01755689
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
A Phase 3 study testing Meningococcal vaccine GSK134612, Cervarix® and Boostrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT… Read more about this study
- Who is it for?
- Ages 9 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612, Cervarix® and Boostrix®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Jan 2013to 29 Apr 2014
- 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 9 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- A female between, and including, 9 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
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- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), with the exception of licensed inactivated influenza vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational product or a non-investigational vaccine/product.
- Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within the last 10 years.
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- History of meningococcal disease since birth.
- History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
- History of encephalopathy within seven days of administration of a previous pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
- Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least 10 years have elapsed since the last dose of tetanus-toxoid containing vaccine.
- Previous vaccination with a tetanus-toxoid containing vaccine within the previous five years.
- Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine (diphtheria-tetanus-whole cell pertussis [DTPw] and/or diphtheria-tetanus-acellular pertussis [DTaP]), not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
- Seizures with or without fever within three days of a previous dose of DTP vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and history directed physical examination.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of any allergic disease/reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy or progressive encephalopathy.
- History of any neurologic disorders or seizures. A history of ADHD or depression or a history of a single, simple febrile seizure does not exclude a subject.
- Major congenital defects or serious chronic illness.
- Previous history of Guillain-Barré Syndrome.
- Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
- Acute disease and/or fever 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.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- Previous administration of MPL or AS04 adjuvant.
- History of chronic alcohol consumption and/or drug abuse.
- Pregnant or lactating female.
- A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612, Cervarix®, Boostrix®
- Keywords
- pertussis, Meningococcal meningitis, Meningococcal infections, HPV, Neisseria meningitidis, Vaccines, conjugate, tetanus, diphtheria, Meningococcal vaccines, Immunogenicity
- Medical subject headings
- Meningococcal Infections, Whooping Cough, Meningitis, Meningococcal, Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612Biological
Also called Nimenrix®
One dose administered intramuscularly (IM) in the deltoid of the right arm.
Cervarix®Biological
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Boostrix®Biological
One dose administered intramuscularly (IM) in the deltoid of the left arm.
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Experimental | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Cervarix® |
| Nimenrix+Cervarix (0,1,6-Month) Group | Experimental | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Cervarix® |
| Cervarix Group | Experimental | Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. Receives: Biological: Cervarix® |
| Nimenrix+Cervarix+Boostrix Group | Experimental | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Cervarix®; Biological: Boostrix® |
| Boostrix+Cervarix Group | Experimental | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Receives: Biological: Cervarix®; Biological: Boostrix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.
Measured: At one month after vaccination with Nimenrix (Month 1)
Anti-HPV-16 and Anti-HPV-18 Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Measured: At one month after vaccination with Cervarix (Month 7)
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.
Measured: At one month after Boostrix vaccination (Month 1)
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.
Measured: At one month after Boostrix vaccination (Month 1)
Secondary outcomes (17)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128
The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.
Measured: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response
rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:
- For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.
- For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination.
Measured: At one month after Nimenrix vaccination (Month 1)
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Measured: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Anti-T Antibody Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.
Measured: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Measured: Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.
Measured: Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)
Anti-HPV-16 and Anti-HPV-18 Concentrations
The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Measured: Prior to and one month after the third dose of Cervarix (Months 0 and 8)
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Booster responses to the PT, FHA and PRN antigens were defined as:
- For initially seronegative subjects (antibody concentrations: < 2.046 IU/ml for anti-FHA, < 2.187 IU/ml for anti-PRN, < 2.693 IU/ml for anti-PT), antibody concentration ≥ 4*cut_off IU/ml at Month 1 post-vaccination;
- For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration < 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration;
- For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration.
Measured: At one month after Boostrix vaccination (Month 1)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Measured: Prior to and one month after Boostrix vaccination (Month 0 and Month 1)
Anti-D and Anti-T Antibody Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Measured: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value
The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.
Measured: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Number of Subjects Reporting Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Reporting Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix
Number of Subjects With Serious Adverse Events SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Month 0 to Month 8)
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: During the entire study period (from Month 0 to Month 8)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: During the entire study period (from Month 0 to Month 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study start11 Jan 2013
- Primary completion29 Apr 2014
- Study completion29 Apr 2014
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
- 1,300 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
- NCT01755689
- Sponsor's protocol ID
- 113823
- Other IDs
- 2012-001876-13
- Status last verified
- Nov 2017
- First submitted
- 13 Dec 2012
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263Rivera L, Chanthavanich P, Poder A, Suryakiran PV, Jastorff A, Van der Wielen M. MenACWY-TT is immunogenic when co-administered with Tdap and AS04-HPV16/18 in girls and young women: Results from a phase III randomized trial. Vaccine. 2018 Jun 22;36(27):3967-3975. doi: 10.1016/j.vaccine.2018.05.051. Epub 2018 May 19.
PubMed 29789243
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age
- ClinicalTrials.gov ID
- NCT01755689
- Acronym / sponsor ID
- 113823
- Conditions
- Infections, Meningococcal
- Keywords
- pertussis, Meningococcal meningitis, Meningococcal infections, HPV, Neisseria meningitidis, Vaccines, conjugate, tetanus, diphtheria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2013 (actual)
- Primary completion
- 29 Apr 2014 (actual)
- Study completion
- 29 Apr 2014 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Experimental | Biological: Meningococcal vaccine GSK134612, Biological: Cervarix®Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| Nimenrix+Cervarix (0,1,6-Month) Group | Experimental | Biological: Meningococcal vaccine GSK134612, Biological: Cervarix®Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| Cervarix Group | Experimental | Biological: Cervarix®Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. |
| Nimenrix+Cervarix+Boostrix Group | Experimental | Biological: Meningococcal vaccine GSK134612, Biological: Cervarix®, Biological: Boostrix®Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| Boostrix+Cervarix Group | Experimental | Biological: Cervarix®, Biological: Boostrix®Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Subjects and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- A female between, and including, 9 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
Key exclusion criteria (30 listed)
- Child in care.
- Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), with the exception of licensed inactivated influenza vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational product or a non-investigational vaccine/product.
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 GSK134612Also: Nimenrix®One dose administered intramuscularly (IM) in the deltoid of the right arm. | Biological | Nimenrix+Cervarix (0,1,6-Month) Group, Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group |
| Cervarix®Three doses administered intramuscularly (IM) in the deltoid of the left arm. | Biological | Boostrix+Cervarix Group, Cervarix Group, Nimenrix+Cervarix (0,1,6-Month) Group, Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group |
| Boostrix®One dose administered intramuscularly (IM) in the deltoid of the left arm. | Biological | Boostrix+Cervarix Group, Nimenrix+Cervarix+Boostrix Group |
Primary outcome
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Time frame: At one month after vaccination with Nimenrix (Month 1)
The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.
Anti-HPV-16 and Anti-HPV-18 Concentrations
Time frame: At one month after vaccination with Cervarix (Month 7)
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
Time frame: At one month after Boostrix vaccination (Month 1)
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At one month after Boostrix vaccination (Month 1)
The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.
17 secondary outcomes
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response
Time frame: At one month after Nimenrix vaccination (Month 1)
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Anti-T Antibody Concentrations
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL
Time frame: Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Time frame: Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)
Anti-HPV-16 and Anti-HPV-18 Concentrations
Time frame: Prior to and one month after the third dose of Cervarix (Months 0 and 8)
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Time frame: At one month after Boostrix vaccination (Month 1)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Time frame: Prior to and one month after Boostrix vaccination (Month 0 and Month 1)
Anti-D and Anti-T Antibody Concentrations
Time frame: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value
Time frame: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Number of Subjects Reporting Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)
Time frame: During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix
Number of Subjects With Serious Adverse Events SAE(s)
Time frame: During the entire study period (from Month 0 to Month 8)
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time frame: During the entire study period (from Month 0 to Month 8)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
Time frame: During the entire study period (from Month 0 to Month 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- Derived from this study: PubMed 29789243Rivera L, Chanthavanich P, Poder A, Suryakiran PV, Jastorff A, Van der Wielen M. MenACWY-TT is immunogenic when co-administered with Tdap and AS04-HPV16/18 in girls and young women: Results from a phase III randomized trial. Vaccine. 2018 Jun 22;36(27):3967-3975. doi: 10.1016/j.vaccine.2018.05.051. Epub 2018 May 19.
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal vaccine GSK134612, Cervarix® and Boostrix® in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 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 3 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 Dominican Republic, Estonia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) (time frame: At one month after vaccination with Nimenrix (Month 1)). The study lists 4 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 NCT01755689, 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 3 Jul 2018.