Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00534638
First received: September 24, 2007
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally.The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Papillomavirus (HPV) Infection |
Biological: GSK Biologicals' HPV Vaccine GSK580299 Biological: Engerix-B™ |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- HPV-16 and/or HPV-18 DNA positivity in all 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HPV-16 and/or HPV-18 DNA positivity in 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
- High-risk HPV DNA positivity in all 18 - 19 year old female study participants [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
- Occurrence, intensity and causal relationship to vaccination of solicited (local and general) symptoms in a subset of subjects. [ Time Frame: Within 7 days after any vaccination ] [ Designated as safety issue: No ]
- Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms in a subset of subjects. [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
- Occurrence of rash and urticaria in a subset of subjects [ Time Frame: Within 30 minutes following vaccination ] [ Designated as safety issue: No ]
- Occurrence of medically significant conditions in a subset of subjects [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
- Occurrence and causal relationship to vaccination of SAEs in a subset of subjects [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
- Occurrence of SAEs assessed by the investigator as possibly related to vaccination in all subjects [ Time Frame: Reported during the entire study period ] [ Designated as safety issue: No ]
- Occurrence of new onset of autoimmune diseases retrieved from hospital discharge registry in all subjects [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
- Occurrence of pregnancies with onset, and their outcomes, retrieved from medical birth registry [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
- Occurrence of CIN3+, retrieved from Finnish Cancer Registry [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
- Anti-HPV-16/18 antibody levels and quality assessed at the time of serum withdrawal in a subset of subjects [ Time Frame: Visits 1, 4, and 5 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68000 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
90% of male and female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Rest of the subjects will receive Engerix-B™ vaccine.
|
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
|
|
Experimental: Group B
90% of the female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Male adolescents and rest of the female adolescents will receive Engerix-B™ vaccine.
|
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
|
|
Active Comparator: Group C
All adolescents will receive Engerix-B™ vaccine.
|
Biological: Engerix-B™
Intramuscular injection, 3 doses
|
Detailed Description:
As GSK Biologicals' HPV vaccine GSK580299 is not licensed for use in boys, the boys included in the current study and receiving the HPV vaccine are considered to be part of a Phase 3 trial. The study is partially blinded as some study participants will be aware of their group allocation but blinded to their treatment allocation. Overall, the study will be open.
Eligibility| Ages Eligible for Study: | 12 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.
- A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.
- Healthy male and female study participants as established by medical history before entering into the study.
- Study participants must not be pregnant. Absence of pregnancy should be verified as per investigator's or delegate's clinical judgement.
- If the study participant is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Previous vaccination against HPV or Hepatitis B virus.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534638
Locations
| Finland | |
| GSK Investigational Site | |
| Aanekoski, Finland, 44100 | |
| GSK Investigational Site | |
| Hameenlinna, Finland, 13100 | |
| GSK Investigational Site | |
| Helsinki, Finland, 00100 | |
| GSK Investigational Site | |
| Hyvinkaa, Finland, 05800 | |
| GSK Investigational Site | |
| Iisalmi, Finland, 74100 | |
| GSK Investigational Site | |
| Jamsa, Finland, 42100 | |
| GSK Investigational Site | |
| Jarvenpaa, Finland, 04400 | |
| GSK Investigational Site | |
| Joensuu, Finland, 80130 | |
| GSK Investigational Site | |
| Jyvaskyla, Finland, 40100 | |
| GSK Investigational Site | |
| Kajaani, Finland, 87100 | |
| GSK Investigational Site | |
| Kemi, Finland, 94100 | |
| GSK Investigational Site | |
| Kokkola, Finland, 67100 | |
| GSK Investigational Site | |
| Kotka, Finland, 48100 | |
| GSK Investigational Site | |
| Kouvola, Finland, 45100 | |
| GSK Investigational Site | |
| Kuopio, Finland, 70100 | |
| GSK Investigational Site | |
| Kuusamo, Finland, 93600 | |
| GSK Investigational Site | |
| Lahti, Finland, 15110 | |
| GSK Investigational Site | |
| Lappeenranta, Finland, 53100 | |
| GSK Investigational Site | |
| Lohja, Finland, 08100 | |
| GSK Investigational Site | |
| Mikkeli, Finland, 50100 | |
| GSK Investigational Site | |
| Oulu, Finland, 90220 | |
| GSK Investigational Site | |
| Pori, Finland, 28100 | |
| GSK Investigational Site | |
| Porvoo, Finland, 06100 | |
| GSK Investigational Site | |
| Rauma, Finland, 26100 | |
| GSK Investigational Site | |
| Rovaniemi, Finland, 96100 | |
| GSK Investigational Site | |
| Salo, Finland, 24100 | |
| GSK Investigational Site | |
| Sastamala, Finland, 38200 | |
| GSK Investigational Site | |
| Savonlinna, Finland, 57100 | |
| GSK Investigational Site | |
| Seinajoki, Finland, 60100 | |
| GSK Investigational Site | |
| Tampere, Finland, 33100 | |
| GSK Investigational Site | |
| Turku, Finland, 20100 | |
| GSK Investigational Site | |
| Vaasa, Finland, 65100 | |
| GSK Investigational Site | |
| Varkaus, Finland, 78200 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00534638 History of Changes |
| Other Study ID Numbers: | 106636 |
| Study First Received: | September 24, 2007 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by GlaxoSmithKline:
|
adolescents cervical cancer Human papillomavirus (HPV vaccine) HPV |
ClinicalTrials.gov processed this record on May 19, 2013