Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

NCT00250276 | Completed Phase 3 Results

• 2 other identifiers: 1047722005-001667-58
• Study Type: interventional
• Target: 798
• Locations: 3 countries
• Sites: 8

Brief Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

Conditions

Infections, Papillomavirus; Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (2)

• Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)

  Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay \[ELISA\] units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.

  At Month 7

• Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18

  Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.

  At Month 7

Secondary Outcomes (14)

• Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18

  At Month 2

• Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18

  At Month 2

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 7-days (Day 0-6) post-vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 7-days (Day 0-6) post-vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 7-days (Day 0-6) post-vaccination

Study Arms (4)

Cervarix Lot1 Group

EXPERIMENTAL

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™

Cervarix Lot2 Group

EXPERIMENTAL

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™

Cervarix Lot3 Group

EXPERIMENTAL

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™

Cervarix Low Group

EXPERIMENTAL

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™

Interventions

Cervarix™ BIOLOGICAL

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Cervarix Lot1 Group; Cervarix Lot2 Group; Cervarix Lot3 Group; Cervarix Low Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to enrolment.
• Subject must have a negative urine pregnancy test.
• Healthy subject before entering the study entry as established by medical history and physical examination.
• Subject must be of non-childbearing potential.

You may not qualify if:

• pregnant or breastfeeding subject.
• previous vaccination against human papillomavirus (HPV).
• Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
• History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Hvidovre, DK-2650, Denmark

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Klaipėda, LT-93200, Lithuania

Location

GSK Investigational Site

Vilnius, LT-07156, Lithuania

Location

GSK Investigational Site

Vilnius, LT-10207, Lithuania

Location

GSK Investigational Site

Krakow, 31-501, Poland

Location

GSK Investigational Site

Poznan, 60-533, Poland

Location

GSK Investigational Site

Warsaw, 01-211, Poland

Location

Related Publications (1)

• Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

  PMID: 19221517 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

None reported.

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: October 28, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 2, 2020
• Results First Posted: March 17, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DK (1); LI (4); PL (3)