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Phase 3 Completed N=1,300 Randomized Prevention

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

Infections, Meningococcal
Source: ClinicalTrials.gov NCT01755689 ↗
Enrolled (actual)
1,300
Serious AEs
1.8%
Results posted
Jul 2018
Primary outcomePrimary: Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) — 5517.1; 5523.5; 4649.6; 4277.3 Titers
◆ Published Evidence
Emerging
6citations · ~1 / year
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 · Open access · Likely link

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 administered alone and Cervarix co-administered with Boostrix.

Linked Publications (2)

  • 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 · 6 citations · Open access · Likely link
  • Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.
    The Cochrane database of systematic reviews · 2025 · 4 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
5517.1; 5523.5; 4649.6; 4277.3; 5091.0; 3598.6
PRIMARY
Anti-HPV-16 and Anti-HPV-18 Concentrations
10.9; 11128.2; 9.8; 5357.0
PRIMARY
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
235; 248; 249; 256
PRIMARY
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
52.9; 73.2; 278.7; 472.4; 193.4; 318.6
SECONDARY
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128
112; 118; 129; 34; 29; 40
SECONDARY
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response
240; 235; 230; 250; 251; 246
SECONDARY
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
236; 255; 151; 253
SECONDARY
Anti-T Antibody Concentrations
1.2; 25.4
SECONDARY
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL
17; 29; 32; 29; 22; 245
SECONDARY
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
0; 0; 0; 0; 0; 228
SECONDARY
Anti-HPV-16 and Anti-HPV-18 Concentrations
10.9; 11128.2; 9.8; 5357.0
SECONDARY
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies
218; 235; 240; 247; 231; 248
SECONDARY
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
214; 223; 250; 256; 239; 248
SECONDARY
Anti-D and Anti-T Antibody Concentrations
0.5; 0.5; 4.7; 6.6; 1.3; 1.3
SECONDARY
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value
156; 153; 240; 252; 235; 244
SECONDARY
Number of Subjects Reporting Solicited Local Symptoms
152; 140; 156; 4; 3; 7
SECONDARY
Number of Subjects Reporting Solicited General Symptoms
23; 18; 13; 36; 23; 0
SECONDARY
Number of Subjects With Unsolicited Adverse Events AE(s)
37; 35; 35; 42; 39
SECONDARY
Number of Subjects With Serious Adverse Events SAE(s)
3; 2; 5; 7; 6
SECONDARY
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
0; 0; 0; 0; 0
SECONDARY
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
3; 0; 1; 0; 2

Eligibility Criteria

Inclusion Criteria

  • 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.
  • 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.

Exclusion Criteria

  • 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.
  • 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 neuro
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01755689) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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