NCT00294047 is a Phase 3 clinical trial of Cervarix in Infections, Papillomavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00294047?

NCT00294047 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00294047?

Interventions in NCT00294047: Cervarix, Placebo control.

What condition does NCT00294047 study?

NCT00294047 studies Infections, Papillomavirus, Papillomavirus Vaccines.

Is NCT00294047 still recruiting?

NCT00294047 is currently completed. Last updated 2 January 2020.

Are results published for NCT00294047?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-02 · How we verify

NCT00294047

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

Completed Phase 3 Results posted Last updated 2 January 2020

What this trial tests

Phase 3 trial testing Cervarix in Infections, Papillomavirus in 5,752 participants. Completed in 29 January 2014.

Timeline

16 February 2006

Primary endpoint
29 January 2014

29 January 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	5,752
Start date	16 February 2006
Primary completion	29 January 2014
Estimated completion	29 January 2014
Sites	75 locations across Netherlands, Russia, Peru, United Kingdom, Mexico, Philippines, Canada, Thailand

Drugs / interventions tested

Cervarix — full drug profile →
Placebo control

Conditions studied

Infections, Papillomavirus — all drugs for Infections, Papillomavirus →
Papillomavirus Vaccines — all drugs for Papillomavirus Vaccines →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

26 and older, female only, with Infections, Papillomavirus or Papillomavirus Vaccines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. Primary · Up to Month 48

CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	36

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	27

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	10

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	14

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	9

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	5

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	9
Aluminium Hydroxide Group	51

HPV-16, overall

Group	Value	95% CI
Cervarix Group	6
Aluminium Hydroxide Group	36

Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). Primary · Up to Month 48

CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	36

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	27

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	10

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	12

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	8

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	4

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	9
Aluminium Hydroxide Group	49

HPV-16, overall

Group	Value	95% CI
Cervarix Group	6
Aluminium Hydroxide Group	35

CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	71

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	53

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	3
Aluminium Hydroxide Group	20

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	3
Aluminium Hydroxide Group	16

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	10

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	6

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	10
Aluminium Hydroxide Group	90

HPV-16, overall

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	63

CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	71

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	53

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	20

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	3
Aluminium Hydroxide Group	14

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	9

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	5

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	10
Aluminium Hydroxide Group	88

HPV-16, overall

Group	Value	95% CI
Cervarix Group	7
Aluminium Hydroxide Group	62

Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Secondary · Up to Month 48

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	6
Aluminium Hydroxide Group	34

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	26

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	8

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	11

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	8

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	3

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	8
Aluminium Hydroxide Group	45

HPV-16, overall

Group	Value	95% CI
Cervarix Group	6
Aluminium Hydroxide Group	34

Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Secondary · Up to Month 48

Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	18

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	12

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	6

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	3

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	2

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	1

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	21

HPV-16, overall

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	14

Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. Secondary · Up to Month 48

Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

HPV-16

Group	Value	95% CI
Cervarix Group	6
Aluminium Hydroxide Group	34

HPV-18

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	11

HPV-31

Group	Value	95% CI
Cervarix Group	4
Aluminium Hydroxide Group	19

HPV-33

Group	Value	95% CI
Cervarix Group	8
Aluminium Hydroxide Group	6

HPV-35

Group	Value	95% CI
Cervarix Group	8
Aluminium Hydroxide Group	13

HPV-39

Group	Value	95% CI
Cervarix Group	20
Aluminium Hydroxide Group	11

HPV-45

Group	Value	95% CI
Cervarix Group	4
Aluminium Hydroxide Group	17

HPV-51

Group	Value	95% CI
Cervarix Group	27
Aluminium Hydroxide Group	26

Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. Secondary · Up to Month 48

Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68

HPV-16

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	14

HPV-18

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	7

HPV-31

Group	Value	95% CI
Cervarix Group	2
Aluminium Hydroxide Group	10

HPV-33

Group	Value	95% CI
Cervarix Group	5
Aluminium Hydroxide Group	5

HPV-35

Group	Value	95% CI
Cervarix Group	3
Aluminium Hydroxide Group	8

HPV-39

Group	Value	95% CI
Cervarix Group	12
Aluminium Hydroxide Group	5

HPV-45

Group	Value	95% CI
Cervarix Group	4
Aluminium Hydroxide Group	8

HPV-51

Group	Value	95% CI
Cervarix Group	11
Aluminium Hydroxide Group	14

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen Secondary · Up to Month 48

CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	4

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	3

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	2

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	6

HPV-16, overall

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	3

HPV-18, overall

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	4

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen Secondary · Up to Month 48

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

HPV-16/18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	7

HPV-16, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	5

HPV-18, DNA- and sero- subjects

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	3

HPV-16/18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	3

HPV-16, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	1

HPV-18, DNA- and sero+ subjects

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	2

HPV-16/18, overall

Group	Value	95% CI
Cervarix Group	1
Aluminium Hydroxide Group	11

HPV-16, overall

Group	Value	95% CI
Cervarix Group	0
Aluminium Hydroxide Group	6

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.

HPV-16/18

Group	Value	95% CI
Cervarix Group	35
Aluminium Hydroxide Group	56

HPV-16

Group	Value	95% CI
Cervarix Group	24
Aluminium Hydroxide Group	42

HPV-18

Group	Value	95% CI
Cervarix Group	13
Aluminium Hydroxide Group	20

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status Secondary · Up to Month 48

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.

Group	Value	95% CI
Cervarix Group	152
Aluminium Hydroxide Group	178

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cervarix Group

Serious: 291/2881 (10%)

Deaths: —

Aluminium Hydroxide Group

Serious: 269/2871 (9%)

Deaths: —

Serious adverse events (327 terms)

Reaction	System	Cervarix Group	Aluminium Hydroxide Group
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	—	—
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	—	—
Appendicitis	Infections and infestations	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Abortion missed	Pregnancy, puerperium and perinatal conditions	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Dengue fever	Infections and infestations	—	—
Blighted ovum	Pregnancy, puerperium and perinatal conditions	—	—
Abortion threatened	Pregnancy, puerperium and perinatal conditions	—	—
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	—	—
Ovarian cyst	Reproductive system and breast disorders	—	—
Pyelonephritis	Infections and infestations	—	—
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	—	—
Gastroenteritis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Suicide attempt	Psychiatric disorders	—	—
Migraine	Nervous system disorders	—	—
Hypertension	Vascular disorders	—	—
Menorrhagia	Reproductive system and breast disorders	—	—
Convulsion	Nervous system disorders	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Uterine polyp	Reproductive system and breast disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Cervarix Group	Aluminium Hydroxide Group
Pain	General disorders	—	—
Headache	General disorders	—	—
Fatigue	General disorders	—	—
Swelling	General disorders	—	—
Redness	General disorders	—	—
Myalgia	General disorders	—	—
Gastrointestinal	General disorders	—	—
Arthralgia	General disorders	—	—
Fever	General disorders	—	—
Urticaria	General disorders	—	—
Headache	Nervous system disorders	—	—
Rash	General disorders	—	—

Most-reported serious reactions: Abortion spontaneous complete, Abortion spontaneous incomplete, Appendicitis, Abortion spontaneous, Uterine leiomyoma, Abortion missed, Cholelithiasis, Dengue fever.

Data from ClinicalTrials.gov NCT00294047 adverse events section.

Sponsor's own description

This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. · · 2018 · cited 289× · PMID 29740819 · DOI 10.1002/14651858.cd009069.pub3
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study.
Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, et al · · 2016 · cited 142× · PMID 27373900 · DOI 10.1016/s1473-3099(16)30120-7
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study.
Skinner SR, Szarewski A, Romanowski B, Garland SM, et al · · 2014 · cited 126× · PMID 25189358 · DOI 10.1016/s0140-6736(14)60920-x
Human Papillomavirus Vaccines.
Markowitz LE, Schiller JT. · · 2021 · cited 105× · PMID 34590141 · DOI 10.1093/infdis/jiaa621
Comparison of different human papillomavirus (HPV) vaccine types and dose schedules for prevention of HPV-related disease in females and males.
Bergman H, Buckley BS, Villanueva G, Petkovic J, et al · · 2019 · cited 90× · PMID 31755549 · DOI 10.1002/14651858.cd013479
Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study.
Skinner SR, Wheeler CM, Romanowski B, Castellsagué X, et al · · 2016 · cited 73× · PMID 26685704 · DOI 10.1002/ijc.29971
Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.
Angelo MG, David MP, Zima J, Baril L, et al · · 2014 · cited 72× · PMID 24644063 · DOI 10.1002/pds.3554
Ten-year immune persistence and safety of the HPV-16/18 AS04-adjuvanted vaccine in females vaccinated at 15-55 years of age.
Schwarz TF, Galaj A, Spaczynski M, Wysocki J, et al · · 2017 · cited 53× · PMID 28984053 · DOI 10.1002/cam4.1155

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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00294047 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 2 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00294047.

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NCT00294047

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (327 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Cervarix

Other GlaxoSmithKline trials

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