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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Visit 5

- 20.09.21 - 1 Formular, 12 Itemgruppen, 22 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Continuation status, Clinical Trials, Demographics Domain, Adverse Event, Colposcopy, Laboratory Procedures, Collection of blood specimen for laboratory procedure, Physical Examination, Pelvis, Cervical Swab Test, Specimen, Cervical, Specimen, Cervical Cytology, Repeat, Specimen, Cervical, Repeat, Questionnaires
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Visit 3

- 20.09.21 - 1 Formular, 9 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Continuation status, Clinical Trials, Adverse Event, Laboratory Procedures, Collection of blood specimen for laboratory procedure, Physical Examination, Pelvis, Cervical Swab Test, Specimen, Cervical, Specimen, Cervical Cytology, Repeat, Questionnaires
Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

HPV Antibody Collection and Shipping Form (NCT00513526)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 2 Sprachen
Itemgruppe: Specimen
AMC-052 Serum HPV Antibody Collection and Shipping Form Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection NCT00513526 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=546E2EAC-07C0-32E8-E044-0003BA3F9857

Infection NCT00513526 Demographic - AMC-052 Demographic Form (DEM) - 2676987v1.0 - AMC-052 Demographic Form (DEM)

- 17.09.21 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Demographics
AMC-052 Demographic Form (DEM) Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=395422A0-6091-42B3-E044-0003BA3F9857

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Medication

- 22.04.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Pharmaceutical Preparations
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Study Conclusion of Year 8

- 22.04.19 - 1 Formular, 11 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Serious Adverse Event, Pregnancy, Information, Blinded Clinical Study, Status, Exclusion Criteria, Withdraw, Investigator Signature, Colposcopy, Diagram, Laboratory Procedures, Usage, Investigator Signature, Unwilling, participation, Indication
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Non-Serious Adverse Events

- 22.04.19 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Non-serious Adverse Event
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Questionnaire

- 22.04.19 - 1 Formular, 5 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, General information section, Sex Behavior, Contraceptive methods, Gynecological History, Other
Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Concomitant Vaccination

- 22.04.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Vaccination, Concomitant Agent
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Colposcopy

- 22.04.19 - 1 Formular, 3 Itemgruppen, 86 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Colposcopy, Document Section, Colposcopy, Document section
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336 - Colposcopy

- 22.04.19 - 1 Formular, 3 Itemgruppen, 86 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Colposcopy, Document Section, Colposcopy, Document section
Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb; NCT00518336 - Visit 4

- 22.04.19 - 1 Formular, 9 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Exclusion Criteria, Demographics Domain, Adverse Event, Colposcopy, Physical Examination, Pelvis, Specimen, Cervical, Specimen, Cervical, Repeat, Specimen, Cervical, Repeat
Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

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