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

NCT01755689 | Completed Phase 3 Results

• 2 other identifiers: 1138232012-001876-13
• Study Type: interventional
• Target: 1,300
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Infections, Meningococcal

Keywords

pertussis; Meningococcal meningitis; Meningococcal infections; HPV; Neisseria meningitidis; Vaccines, conjugate; tetanus; diphtheria; Meningococcal vaccines; Immunogenicity

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  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

  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

  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

  Prior to and one month after vaccination with Nimenrix (Months 0 and 1)

• Anti-T Antibody Concentrations

  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

  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]

Study Arms (5)

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.

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.

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.

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.

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.

Biological: Cervarix®; Biological: Boostrix®

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the right arm.

Also known as: Nimenrix®

Nimenrix+Cervarix (0,1,6-Month) Group; Nimenrix+Cervarix (1,2,7-Month) Group; Nimenrix+Cervarix+Boostrix Group

Cervarix® BIOLOGICAL

Three doses administered intramuscularly (IM) in the deltoid of the left arm.

Boostrix+Cervarix Group; Cervarix Group; Nimenrix+Cervarix (0,1,6-Month) Group; Nimenrix+Cervarix (1,2,7-Month) Group; Nimenrix+Cervarix+Boostrix Group

Boostrix® BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the left arm.

Boostrix+Cervarix Group; Nimenrix+Cervarix+Boostrix Group

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

Related Publications (2)

• 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.

  PMID: 41276263 DERIVED

• Rivera 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.

  PMID: 29789243 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Whooping Cough; Meningitis, Meningococcal; Tetanus; Diphtheria

Interventions

human papillomavirus vaccine, L1 type 16, 18; Boostrix

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 24, 2012
• Study Start: January 11, 2013
• Primary Completion: April 29, 2014
• Study Completion: April 29, 2014
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2017-11

Locations

ES (1); TH (1); DO (1)