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


Phase 3
4 Years
25 Years
Open (Enrolling)
Female
Cervical Neoplasia, Human Papillomavirus (HPV) Type 16/18 Infections

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Trial Information

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


The study will be conducted in a partially blinded manner:

- The study will be single-blind for the HPV_2D and MMR_DTPa groups up to the Month 12
visit due to the difference in the visual appearance of the study vaccines. Between
Month 12 and study conclusion (Month 36), the study will be open with respect to HPV_2D
group.

- The study will be open with respect to the HPV_2D CO group as subjects in this group
will be receiving two vaccines co-administered at each scheduled vaccination visit.

- The study will be open with respect to the HPV_3D group as subjects in this group will
be receiving three injections.


Inclusion Criteria:



All subjects in the 4-6 years age groups must satisfy ALL the following criteria at study
entry:

- 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.

All subjects in the 15-25 years age group must satisfy ALL the following criteria at study
entry:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol and subjects who the investigator believes that parent(s)/LAR(s) can and
will comply with the requirements of the protocol.

- A female between, and including, 15 and 25 years of age at the time of the first
vaccination.

- Written informed consent obtained from the subject prior to enrolment in the study.
For subjects below the legal age of consent, written informed consent has to be
obtained from the parent(s)/LAR(s) of the subject and, in addition, the subject
should sign and personally date a written informed assent.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Female subjects of non-childbearing potential.

- 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:

For all groups:

- 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 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, egg protein, etc.

- 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.

- 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.

- 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.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose(s).

Additional exclusion criteria for subjects in the 4-6 years age groups only:

- 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.

- 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 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 within 48 hours of administration of previous doses
of DTP vaccine.

- Idiopathic thrombocytopenic purpura or bleeding disorders.

- Additional exclusion criteria for subjects in the 15-25 years age group only:
Pregnant or breastfeeding.

- A woman planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the vaccination phase of the study, i.e.
up to two months after the last vaccine dose.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

The occurrence of solicited local adverse events (AEs) in Groups HPV_2D and MMR_DTPa.

Outcome Time Frame:

During the 7-day period (Days 0-6) following each vaccination

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Study ID:

115887

NCT ID:

NCT01627561

Start Date:

October 2012

Completion Date:

April 2016

Related Keywords:

  • Cervical Neoplasia
  • Human Papillomavirus (HPV) Type 16/18 Infections
  • Immune response
  • Human papillomavirus
  • HPV vaccine
  • Safety
  • Neoplasms

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