A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years
- Subjects who the investigator believes that they and their parents/legally acceptable
representatives can, and will, comply with the requirements of the protocol should be
enrolled in the study.
- A female between, and including, 10 and 18 years of age at the time of the first
- Written informed consent/assent obtained from the subject prior to enrolment. For
subjects above the legal age of consent, written informed consent must be obtained
from the subject. For subjects below legal age of consent, written informed consent
obtained from the subject's parent/LAR, and written informed assent must be obtained
from the subject.
- Healthy subjects, as established by medical history and history-directed physical
examination, before entering into the study.
- Previously completed routine childhood vaccinations according to the recommended
vaccination schedule at the time.
- Subjects must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential, or if she is of childbearing
potential, she must practice adequate contraception for 30 days prior to vaccination,
have a negative pregnancy test and must agree to continue such precautions for two
months after completion of the vaccination series. Subjects who reach menarche during
the study, and therefore become of childbearing potential, must agree to follow the
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period (up to Month 12/13).
- 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).
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days before and 30 days after each dose of vaccine(s). Administration of
routine vaccines up to 8 days before the first dose of study vaccine is allowed.
Enrolment will be deferred until the subject is outside of specified window.
- A woman 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.
- Pregnant or breastfeeding women.
- 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 components of the investigational vaccine
- Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus
(Td) booster or dTpa vaccine within the previous five years.
- Administration of a pre-school booster of Oral Polio Vaccine (OPV) or Inactivated
Polio Virus (IPV) vaccine (4 or 5th dose) within the previous five years.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, hepatic or renal
functional abnormality or thrombocytopenia, as determined by previous physical
examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of
- History of encephalopathy within seven days of administration of a previous dose of
pertussis vaccine that is not attributable to another identifiable cause.
- Temperature of >=40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw
and/or DTPa), not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP
vaccine (DTPw and/or DTPa).
- Seizures with or without fever within three days of a prior dose of DTP vaccine
(Diphtheria, Tetanus, whole cell Pertussis vaccine DTPw and/or Diphtheria, Tetanus,
acellular Pertussis vaccine DTPa).
- Persistent, inconsolable crying lasting >=3 hours, occurring within 48 hours of a
prior dose of DTP vaccine (DTPw and/or DTPa).
- Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus
toxoid within the previous 10 years.
- Known exposure to diphtheria or household exposure to pertussis within 30 days before
(i.e., Day 0-29) vaccination with Diphtheria, Tetanus, acellular Pertussis and
inactivated polio virus vaccine (dTpa-IPV).
- Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days
before (i.e., Day 0-29) vaccination with dTpa-IPV.
- Presence of a contra-indication to vaccination according to the product leaflet of
the commercially available dTpa-IPV vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period. Enrolment will be postponed until the subject is outside the specified