NCT00546078 is a Phase 2 clinical trial of Cervarix™ in Infections, Papillomavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00546078?

NCT00546078 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00546078?

Interventions in NCT00546078: Cervarix™.

What condition does NCT00546078 study?

NCT00546078 studies Infections, Papillomavirus.

Is NCT00546078 still recruiting?

NCT00546078 is currently completed. Last updated 26 June 2018.

Are results published for NCT00546078?

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

Last reviewed 2018-06-26 · How we verify

NCT00546078

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

Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

Completed Phase 2 Results posted Last updated 26 June 2018

What this trial tests

Phase 2 trial testing Cervarix™ in Infections, Papillomavirus in 116 participants. Completed in 1 December 2009.

Timeline

14 January 2008

Primary endpoint
22 December 2008

1 December 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	116
Start date	14 January 2008
Primary completion	22 December 2008
Estimated completion	1 December 2009
Sites	17 locations across Canada, United States

Drugs / interventions tested

Cervarix™

Conditions studied

Infections, Papillomavirus — all drugs for Infections, Papillomavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 15 to 25, female only, with Infections, Papillomavirus. 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 Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values Primary · At Day 7 and Month 1 (Day 30)

Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Anti-HPV-16 at Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	61
Cervarix™ 3-Dose Group	30

Anti-HPV-16 at Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	57
Cervarix™ 3-Dose Group	45

Anti-HPV-18 at Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	61
Cervarix™ 3-Dose Group	26

Anti-HPV-18 at Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	57
Cervarix™ 3-Dose Group	45

Anti-HPV-16 and Anti-HPV-18 Antibody Titers Primary · At Day 7 and at Month 1 (Day 30)

Titers are given as geometric mean titers (GMTs) calculated on all subjects.

anti-HPV-16 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	5894.9	4734.0 – 7340.7
Cervarix™ 3-Dose Group	67.9	27.2 – 169.7

anti-HPV-16 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	15410.7	12807.9 – 18542.4
Cervarix™ 3-Dose Group	1231.1	709.6 – 2135.9

anti-HPV-18 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	3916.2	3087.7 – 4967.0
Cervarix™ 3-Dose Group	20.7	10.2 – 42.2

anti-HPV-18 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	8362.7	6930.4 – 10091.1
Cervarix™ 3-Dose Group	442.0	269.8 – 724.3

Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values Secondary · At Month 7 and Month 18

Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Anti-HPV-16 at Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	55
Cervarix™ 3-Dose Group	43

Anti-HPV-16 at Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	49
Cervarix™ 3-Dose Group	40

Anti-HPV-18 at Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	55
Cervarix™ 3-Dose Group	43

Anti-HPV-18 at Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	49
Cervarix™ 3-Dose Group	40

Anti-HPV-16 and Anti-HPV-18 Antibody Titers Secondary · At Month 7 and Month 18

Titers are given as GMTs calculated on all subjects.

Anti-HPV-16 at Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	5826.9	4742.4 – 7159.5
Cervarix™ 3-Dose Group	7166.5	5954.3 – 8625.5

Ant-HPV-16 at Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	3936.6	3128.7 – 4953.1
Cervarix™ 3-Dose Group	1626.9	1252.4 – 2113.5

Anti-HPV-18 at Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	2940.3	2385.0 – 3625.0
Cervarix™ 3-Dose Group	3584.3	2913.9 – 4408.9

Ant-HPV-18 at Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	1802.5	1407.9 – 2307.6
Cervarix™ 3-Dose Group	520.1	382.9 – 706.4

Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL Secondary · Day 0, Month 1 (Day 30), Month 7 and Month 18

anti-HPV-31 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	61
Cervarix™ 3-Dose Group	20

anti-HPV-31 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	58
Cervarix™ 3-Dose Group	31

anti-HPV-31 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	55
Cervarix™ 3-Dose Group	43

anti-HPV-31 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	48
Cervarix™ 3-Dose Group	35

anti-HPV-45 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	61
Cervarix™ 3-Dose Group	18

anti-HPV-45 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	58
Cervarix™ 3-Dose Group	32

anti-HPV-45 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	55
Cervarix™ 3-Dose Group	43

anti-HPV-45 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	49
Cervarix™ 3-Dose Group	35

Anti-HPV-31 and Anti-HPV-45 Antibody Titers Secondary · Day 7, Month 1 (Day 30), Month 7 and Month 18

Titers are given as geometric mean titers (GMTs) calculated on all subjects.

anti-HPV-31 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	2075.3	1635.4 – 2633.6
Cervarix™ 3-Dose Group	90.7	55.8 – 147.4

anti-HPV-31 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	3705.8	2902.4 – 4731.5
Cervarix™ 3-Dose Group	192.1	110.7 – 333.4

anti-HPV-31 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	1193.8	879.6 – 1620.2
Cervarix™ 3-Dose Group	878.3	641.2 – 1202.9

anti-HPV-31 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	667.0	470.2 – 946.3
Cervarix™ 3-Dose Group	225.4	147.9 – 343.6

anti-HPV-45 Day 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	2347.7	1869.9 – 2905.6
Cervarix™ 3-Dose Group	76.4	49.9 – 116.9

anti-HPV-45 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	4491.5	3655.6 – 5518.5
Cervarix™ 3-Dose Group	189.9	113.6 – 317.4

anti-HPV-45 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	1503.1	1149.7 – 1965.0
Cervarix™ 3-Dose Group	981.0	778.6 – 1236.0

anti-HPV-45 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	890.2	663.6 – 1194.1
Cervarix™ 3-Dose Group	185.1	129.5 – 264.5

Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types Secondary · Day 0, Month 1 [Day 30], Month 7 and Month 18

CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma. An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.

HPV-16, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	24
Cervarix™ 3-Dose Group	0

HPV-16, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	25
Cervarix™ 3-Dose Group	5

HPV-16, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	22
Cervarix™ 3-Dose Group	16

HPV-16, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	23
Cervarix™ 3-Dose Group	13

HPV-18, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	17
Cervarix™ 3-Dose Group	1

HPV-18, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	24
Cervarix™ 3-Dose Group	3

HPV-18, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	21
Cervarix™ 3-Dose Group	13

HPV-18, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	20
Cervarix™ 3-Dose Group	8

Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types Secondary · Day 0, Month 1 [Day 30], Month 7 and Month 18

CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma. An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.

HPV-16, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	0
Cervarix™ 3-Dose Group	0

HPV-16, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	1
Cervarix™ 3-Dose Group	0

HPV-16, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	0
Cervarix™ 3-Dose Group	2

HPV-16, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	1
Cervarix™ 3-Dose Group	0

HPV-18, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	0
Cervarix™ 3-Dose Group	0

HPV-18, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	0
Cervarix™ 3-Dose Group	1

HPV-18, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	0
Cervarix™ 3-Dose Group	1

HPV-18, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	1
Cervarix™ 3-Dose Group	0

Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types Secondary · Day 0, Month 1 [Day 30], Month 7 and Month 18

B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay. A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.

HPV-16, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	20
Cervarix™ 3-Dose Group	1

HPV-16, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	27
Cervarix™ 3-Dose Group	21

HPV-16, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	26
Cervarix™ 3-Dose Group	20

HPV-16, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	17
Cervarix™ 3-Dose Group	11

HPV-18, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	21
Cervarix™ 3-Dose Group	3

HPV-18, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	27
Cervarix™ 3-Dose Group	18

HPV-18, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	26
Cervarix™ 3-Dose Group	20

HPV-18, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	18
Cervarix™ 3-Dose Group	15

Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples Secondary · Day 0, Month 1 (Day 30), Month 7 and Month 18

Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay. Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with \< 200 erythrocytes per microliter.

Anti-HPV-16 Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	8
Cervarix™ 3-Dose Group	2

Anti-HPV-16 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	13
Cervarix™ 3-Dose Group	5

Anti-HPV-16 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	12
Cervarix™ 3-Dose Group	11

Anti-HPV-16 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	15
Cervarix™ 3-Dose Group	14

Anti-HPV-18 Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	9
Cervarix™ 3-Dose Group	1

Anti-HPV-18 Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	13
Cervarix™ 3-Dose Group	6

Anti-HPV-18 Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	12
Cervarix™ 3-Dose Group	11

Anti-HPV-18 Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	13
Cervarix™ 3-Dose Group	13

Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples Secondary · Day 0, Month 1 (Day 30), Month 7 and Month 18

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with \< 200 erythrocytes per microliter.

Anti-HPV-16, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	323.8	84.0 – 1247.3
Cervarix™ 3-Dose Group	147.0	93.3 – 231.6

Anti-HPV-16, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	562.1	312.8 – 1010.3
Cervarix™ 3-Dose Group	331.2	100.3 – 1093.6

Anti-HPV-16, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	220.5	104.7 – 464.7
Cervarix™ 3-Dose Group	299.2	153.4 – 583.3

Anti-HPV-16, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	110.9	46.2 – 266.0
Cervarix™ 3-Dose Group	52.8	34.3 – 81.4

Anti-HPV-18, Day 0

Group	Value	95% CI
Cervarix™ 4-Dose Group	177.1	43.6 – 719.0
Cervarix™ 3-Dose Group	58.6	58.6 – 58.6

Anti-HPV-18, Month 1

Group	Value	95% CI
Cervarix™ 4-Dose Group	375.1	257.8 – 545.8
Cervarix™ 3-Dose Group	54.0	10.1 – 288.5

Anti-HPV-18, Month 7

Group	Value	95% CI
Cervarix™ 4-Dose Group	111.5	57.1 – 217.7
Cervarix™ 3-Dose Group	178.0	88.0 – 359.9

Anti-HPV-18, Month 18

Group	Value	95% CI
Cervarix™ 4-Dose Group	73.6	31.2 – 173.4
Cervarix™ 3-Dose Group	29.6	16.0 – 54.8

Number of Subjects Reporting Solicited Local Symptoms Secondary · Within 7 days after vaccination

Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

Pain

Group	Value	95% CI
Cervarix™ 4-Dose Group	61
Cervarix™ 3-Dose Group	45

Redness

Group	Value	95% CI
Cervarix™ 4-Dose Group	24
Cervarix™ 3-Dose Group	18

Swelling

Group	Value	95% CI
Cervarix™ 4-Dose Group	22
Cervarix™ 3-Dose Group	16

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cervarix™ 4-Dose Group

Serious: 1/65 (2%)

Deaths: —

Cervarix™ 3-Dose Group

Serious: 1/50 (2%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Cervarix™ 4-Dose Group	Cervarix™ 3-Dose Group
Cholecystitis	Hepatobiliary disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Cervarix™ 4-Dose Group	Cervarix™ 3-Dose Group
Pain	General disorders	—	—
Fatigue	General disorders	—	—
Headache	General disorders	—	—
Myalgia	General disorders	—	—
Redness	General disorders	—	—
Swelling	General disorders	—	—
Gastrointestinal symptoms	General disorders	—	—
Arthralgia	General disorders	—	—
Fever	General disorders	—	—
Dizziness	Nervous system disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Chlamydial infection	Infections and infestations	—	—

Most-reported serious reactions: Cholecystitis, Pulmonary embolism.

Data from ClinicalTrials.gov NCT00546078 adverse events section.

Sponsor's own description

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

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

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
Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women.
Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, et al · · 2012 · cited 26× · PMID 23063422 · DOI 10.1016/j.vaccine.2012.09.037

Verify or expand the search:

Other trials of Cervarix™

Trials testing the same drug.

NCT00578227 — Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy · Phase 3 · completed
NCT00250276 — Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. · Phase 3 · completed
NCT00122681 — Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK · Phase 3 · completed

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00546078 (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: 26 June 2018

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/NCT00546078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00546078

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 (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Cervarix™

Other GlaxoSmithKline trials

Verify against primary sources