Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old

NCT ID: NCT01627561

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-15
• Study Completion Date: 2016-10-06

Brief Summary

The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cervarix Group

Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

Group Type: EXPERIMENTAL

Cervarix

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.

Priorix + Infanrix Group

Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

Group Type: ACTIVE_COMPARATOR

Priorix

Intervention Type: BIOLOGICAL

1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.

Infanrix

Intervention Type: BIOLOGICAL

1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.

Interventions

Cervarix

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.

Intervention Type: BIOLOGICAL

Priorix

1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.

Intervention Type: BIOLOGICAL

Infanrix

1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.

Intervention Type: BIOLOGICAL

Other Intervention Names

HPV; MMR; DTPa

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
• A female between, and including, 4 and 6 years of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries.
• Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries.

Exclusion Criteria

• Child in care.
• Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and/or poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
• History of any reactions or hypersensitivity likely to be exacerbated by any component of the study vaccines, including latex and/or obvious allergic reactions to neomycin (a history of contact dermatitis to neomycin is not a contraindication), egg protein, etc. (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock subsequent to egg ingestion).
• Cancer or autoimmune disease under treatment.
• 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 or a non-investigational product (pharmaceutical product or device).
• Previous administration of MPL or AS04 adjuvant.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• Documented human immunodeficiency virus (HIV)-positive subject.
• Major congenital defects or serious chronic illness.
• History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes administration of any of the study vaccines.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine(s).
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. Enrolment can be deferred until condition is resolved.
• Previous administration of the fifth dose of DTP vaccine and/or the second dose of MMR vaccine or planned administration of DTP vaccine and/or MMR vaccine outside the study (during the study period from Day 0 to Month 12).
• History of tetanus, diphtheria, pertussis, measles, mumps and/or rubella.
• Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa.
• Known exposure to measles, mumps and/or rubella 30 days prior to vaccination with the MMR study vaccine.
• Confirmed or suspected tuberculosis.
• Severe allergic reactions (e.g. anaphylaxis or severe Arthus-type hypersensitivity reactions) following the administration of previous dose(s) of DTP or MMR vaccines.
• Hyperpyrexia (≥ 40.5°C) within 48 hours of administration of previous doses of DTP or MMR vaccines.
• Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of administration of previous doses of DTP vaccine.
• Collapse or shocking-like state (hypotonic-hyporesponsive episode) within 48 hours of administration of previous doses of DTP vaccine.
• Idiopathic thrombocytopenic purpura or bleeding disorders.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose(s). (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bogotá, , Colombia

GSK Investigational Site

Yopal, Casanare, , Colombia

GSK Investigational Site

México, , Mexico

GSK Investigational Site

Panama City, , Panama

Countries

Colombia; Mexico; Panama

References

Lin L, Parra MM, Sierra VY, Cespedes AS, Granados MA, Luque A, Damaso S, Castrejon Alba MM, Romano-Mazzotti L, Struyf F. Safety and Immunogenicity of the HPV-16/18 AS04-adjuvanted Vaccine in 4-6-year-old Girls: Results to Month 12 From a Randomized Trial. Pediatr Infect Dis J. 2018 Apr;37(4):e93-e102. doi: 10.1097/INF.0000000000001871.

Reference Type: BACKGROUND

PMID: 29424799 (View on PubMed)

Lin L, Macias Parra M, Sierra VY, Salas Cespedes A, Granados MA, Luque A, Karkada N, Castrejon Alba MM, Romano-Mazzotti L, Borys D, Struyf F. Long-term Immunogenicity and Safety of the AS04-adjuvanted Human Papillomavirus-16/18 Vaccine in Four- to Six-year-old Girls: Three-year Follow-up of a Randomized Phase III Trial. Pediatr Infect Dis J. 2019 Oct;38(10):1061-1067. doi: 10.1097/INF.0000000000002437.

Reference Type: BACKGROUND

PMID: 31469776 (View on PubMed)

Other Identifiers

2011-005604-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

115887

Identifier Type: -

Identifier Source: org_study_id