NCT00128661

Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

Completed Phase 3 Results posted Last updated 8 March 2019

What this trial tests

Phase 3 trial testing human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine in Cervical Cancer in 7,466 participants. Completed in 31 December 2010.

Timeline

30 June 2004

Primary endpoint
31 December 2010

31 December 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	7,466
Start date	30 June 2004
Primary completion	31 December 2010
Estimated completion	31 December 2010
Sites	1 location across Costa Rica

Drugs / interventions tested

• human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine — full drug profile →
• hepatitis A inactivated virus vaccine — full drug profile →

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Precancerous Condition — all drugs for Precancerous Condition →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 25, female only, with Cervical Cancer or Precancerous Condition. 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 Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. Primary · From Month 6 up to Month 48

CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.

HPV16 Associated CIN2+ (N=2464;2452)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	9

HPV18 Associated CIN2+ (N=2567; 2593)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	2

HPV16 and/or 18 Associated CIN2+ (N=2635;2677)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	10

Number of Cervical Infection With HPV16 or HPV18. Secondary · From Month 6 up to Month 48

Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type

HPV16 Cervical Infection (N=2464;2452)

Group	Value	95% CI
Cervarix Group	50
Havrix Group	251

HPV18 Cervical Infection (N=2567;2593)

Group	Value	95% CI
Cervarix Group	32
Havrix Group	177

HPV16 and/or 18 Cervical Infection (N=2635;2677)

Group	Value	95% CI
Cervarix Group	78
Havrix Group	387

Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type Secondary · From Month 6 up to Month 48

Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen. Note: The assay did not distinguish between HPV types 68 and 73. CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type

HPV16 Associated CIN2+ (N=2464;2452)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	9

HPV18 Associated CIN2+ (N=2567,2593)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	2

HPV31 Associated CIN2+ (N=2525;2546)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	6

HPV33 Associated CIN2+ (N=2596;2645)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	3

HPV35 Associated CIN2+ (N=2593;2631)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	4

HPV39 Associated CIN2+ (N=2528;2581)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	0

HPV45 Associated CIN2+ (N=2573;2622)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	1

HPV51 Associated CIN2+ (N=2453;2539)

Group	Value	95% CI
Cervarix Group	1
Havrix Group	6

Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases Secondary · From Month 6 up to Month 48

Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months. Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.

Persistent HPV16 Infection (N=2464,2452)

Group	Value	95% CI
Cervarix Group	10
Havrix Group	71

Persistent HPV18 Infection (N=2567;2593)

Group	Value	95% CI
Cervarix Group	0
Havrix Group	37

Persistent HPV16 and/or 18 Infection (N=2635;2677)

Group	Value	95% CI
Cervarix Group	10
Havrix Group	104

Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort. Secondary · Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination. Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)

HPV-16 [before vaccination] (N=194;156)

Group	Value	95% CI
Cervarix Group	6.7	5.7 – 7.8
Havrix Group	8.2	6.7 – 10.0

HPV-16 [at Month 1] (N=196,157)

Group	Value	95% CI
Cervarix Group	646.6	549.3 – 761.1
Havrix Group	7.9	6.5 – 9.6

HPV-16 [at Month 6] (N=195,156)

Group	Value	95% CI
Cervarix Group	771.5	668.3 – 890.7
Havrix Group	8.4	6.9 – 10.3

HPV-16 [at Month 7] (N=195,157)

Group	Value	95% CI
Cervarix Group	3261	2959 – 3595
Havrix Group	8.5	6.9 – 10.3

HPV-16 [at Month 12] (N=182,146)

Group	Value	95% CI
Cervarix Group	2090	1822 – 2398
Havrix Group	8.3	6.7 – 10.4

HPV-16 [at Month 18] (N=25,17)

Group	Value	95% CI
Cervarix Group	1045	776.0 – 1408
Havrix Group	10.4	4.8 – 22.7

HPV-16 [at Month 24] (N=175,137)

Group	Value	95% CI
Cervarix Group	1486	1293 – 1709
Havrix Group	8.6	6.9 – 10.7

HPV-16 [at Month 30] (N=19,15)

Group	Value	95% CI
Cervarix Group	1070	747.5 – 1532
Havrix Group	11.9	5.1 – 28.0

Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort Secondary · Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

HPV-18 [before vaccination] (N=200;173)

Group	Value	95% CI
Cervarix Group	5.4	4.8 – 6.1
Havrix Group	6.2	5.2 – 7.4

HPV-18 [at Month 1] (N=203;170)

Group	Value	95% CI
Cervarix Group	372.7	322.8 – 430.3
Havrix Group	6.4	5.4 – 7.6

HPV-18 [at Month 6] (N=203;175)

Group	Value	95% CI
Cervarix Group	532.2	467.5 – 605.9
Havrix Group	6.7	5.6 – 7.9

HPV-18 [at Month 7] (N=202;175)

Group	Value	95% CI
Cervarix Group	3276	3001 – 3576
Havrix Group	6.8	5.7 – 8.1

HPV-18 [at Month 12] (N=190;166)

Group	Value	95% CI
Cervarix Group	1082	942.0 – 1242
Havrix Group	7.0	5.7 – 8.5

HPV-18 [at Month 18] (N=28;20)

Group	Value	95% CI
Cervarix Group	502.4	339.1 – 744.5
Havrix Group	6.7	3.8 – 12.1

HPV-18 [at Month 24] (N=178;150)

Group	Value	95% CI
Cervarix Group	633.0	551.5 – 726.6
Havrix Group	6.9	5.6 – 8.4

HPV-18 [at Month 30] (N=17;19)

Group	Value	95% CI
Cervarix Group	403.8	257.8 – 632.5
Havrix Group	6.4	3.8 – 10.5

HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test) Secondary · Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

HPV-16 [before vaccination] (N=196;158)

Group	Value	95% CI
Cervarix Group	21.1	20.5 – 21.8
Havrix Group	21.4	20.6 – 22.3

HPV-16 [at Month 1] (N=182;155)

Group	Value	95% CI
Cervarix Group	58.5	48.3 – 70.8
Havrix Group	21.5	20.7 – 22.3

HPV-16 [at Month 6] (N=189;156)

Group	Value	95% CI
Cervarix Group	80.9	70.3 – 93.1
Havrix Group	21.5	20.6 – 22.4

HPV-16 [at Month 7] (N=193;158)

Group	Value	95% CI
Cervarix Group	1047	926.3 – 1183
Havrix Group	21.4	20.6 – 22.3

HPV-16 [at Month 12] (N=175;146)

Group	Value	95% CI
Cervarix Group	291.4	253.7 – 334.8
Havrix Group	22.6	20.8 – 24.5

HPV-16 [at Month 18] (N=24;17)

Group	Value	95% CI
Cervarix Group	116.6	83.2 – 163.3
Havrix Group	20.5	20.5 – 20.5

HPV-16 [at Month 24] (N=169;138)

Group	Value	95% CI
Cervarix Group	184.6	163.0 – 209.1
Havrix Group	21.4	20.6 – 22.3

HPV-16 [at Month 30] (N=18;15)

Group	Value	95% CI
Cervarix Group	112.4	78.7 – 160.6
Havrix Group	20.5	20.5 – 20.5

HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test) Secondary · Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

HPV-18 [before vaccination] (N=203;176)

Group	Value	95% CI
Cervarix Group	55.0	55.0 – 55.0
Havrix Group	55.7	54.7 – 56.7

HPV-18 [at Month 1] (N=197;173)

Group	Value	95% CI
Cervarix Group	99.1	88.0 – 111.5
Havrix Group	55.3	54.7 – 55.8

HPV-18 [at Month 6] (N=195;175)

Group	Value	95% CI
Cervarix Group	111.4	100.2 – 123.9
Havrix Group	55.4	54.6 – 56.3

HPV-18 [at Month 7] (N=198;176)

Group	Value	95% CI
Cervarix Group	823.6	737.7 – 919.5
Havrix Group	55.0	55.0 – 55.0

HPV-18 [at Month 12] (N=182;166)

Group	Value	95% CI
Cervarix Group	231.1	203.2 – 262.7
Havrix Group	56.7	54.7 – 58.8

HPV-18 [at Month 18] (N=28;20)

Group	Value	95% CI
Cervarix Group	121.8	89.5 – 165.8
Havrix Group	55.0	55.0 – 55.0

HPV-18 [at Month 24] (N=170;154)

Group	Value	95% CI
Cervarix Group	140.8	123.8 – 160.2
Havrix Group	55.0	55.0 – 55.0

HPV-18 [at Month 30] (N=17;19)

Group	Value	95% CI
Cervarix Group	89.5	67.6 – 118.7
Havrix Group	55.0	55.0 – 55.0

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Secondary · Within 60 minutes after vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).

Any pain

Group	Value	95% CI
Cervarix Group	1627
Havrix Group	1610

Grade 3 pain

Group	Value	95% CI
Cervarix Group	25
Havrix Group	20

Any redness

Group	Value	95% CI
Cervarix Group	544
Havrix Group	501

Grade 3 redness > 50 mm

Group	Value	95% CI
Cervarix Group	0
Havrix Group	2

Any swelling

Group	Value	95% CI
Cervarix Group	207
Havrix Group	201

Grade 3 swelling > 50 mm

Group	Value	95% CI
Cervarix Group	0
Havrix Group	1

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. Secondary · Within 60 minutes after vaccination

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \> 39.0°C.

Any fatigue

Group	Value	95% CI
Cervarix Group	512
Havrix Group	502

Grade 3 fatigue

Group	Value	95% CI
Cervarix Group	6
Havrix Group	5

Any myalgia

Group	Value	95% CI
Cervarix Group	257
Havrix Group	232

Grade 3 myalgia

Group	Value	95% CI
Cervarix Group	0
Havrix Group	1

Any arthralgia

Group	Value	95% CI
Cervarix Group	58
Havrix Group	64

Grade 3 arthralgia

Group	Value	95% CI
Cervarix Group	0
Havrix Group	1

Any gastrointestinal

Group	Value	95% CI
Cervarix Group	191
Havrix Group	171

Grade 3 gastrointestinal

Group	Value	95% CI
Cervarix Group	0
Havrix Group	0

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. Secondary · From Day 3 to Day 6 after vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).

Any pain

Group	Value	95% CI
Cervarix Group	202
Havrix Group	74

Grade 3 pain

Group	Value	95% CI
Cervarix Group	0
Havrix Group	0

Any redness

Group	Value	95% CI
Cervarix Group	6
Havrix Group	1

Grade 3 redness

Group	Value	95% CI
Cervarix Group	1
Havrix Group	0

Any swelling

Group	Value	95% CI
Cervarix Group	23
Havrix Group	1

Grade 3 swelling

Group	Value	95% CI
Cervarix Group	7
Havrix Group	0

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. Secondary · From Day 3 to Day 6 after vaccination

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \> 39.0°C.

Any pain

Group	Value	95% CI
Cervarix Group	214
Havrix Group	189

Grade 3 pain

Group	Value	95% CI
Cervarix Group	2
Havrix Group	0

Any myalgia

Group	Value	95% CI
Cervarix Group	250
Havrix Group	211

Grade 3 myalgia

Group	Value	95% CI
Cervarix Group	1
Havrix Group	0

Any arthralgia

Group	Value	95% CI
Cervarix Group	44
Havrix Group	32

Grade 3 arthralgia

Group	Value	95% CI
Cervarix Group	0
Havrix Group	0

Any gastrointestinal

Group	Value	95% CI
Cervarix Group	157
Havrix Group	119

Grade 3 gastrointestinal

Group	Value	95% CI
Cervarix Group	0
Havrix Group	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs: within 60 minutes after vaccination for all participants [please refer to Participant Flow Pre-assignment Details for population description]; From Day 3 to Day 6 post-vaccination for a 10% random subset of participants. SAEs: From Month 0 up to Month 48. Unsolicited AEs: From Month 0 up to Month 48 and Within 30 days (Days 0-29) after vaccination. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cervarix Group

Serious: 912/3727 (24%)

Deaths: —

Havrix Group

Serious: 891/3739 (24%)

Deaths: —

Serious adverse events (266 terms)

Reaction	System	Cervarix Group	Havrix Group
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	—	—
False labour	Pregnancy, puerperium and perinatal conditions	—	—
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	—	—
Foetal distress syndrome	Pregnancy, puerperium and perinatal conditions	—	—
Abortion missed	Pregnancy, puerperium and perinatal conditions	—	—
Caesarean section	Surgical and medical procedures	—	—
Uterine hypotonus	Pregnancy, puerperium and perinatal conditions	—	—
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	—	—
Dengue fever	Infections and infestations	—	—
Cephalo-pelvic disproportion	Pregnancy, puerperium and perinatal conditions	—	—
Abortion threatened	Pregnancy, puerperium and perinatal conditions	—	—
Breech presentation	Pregnancy, puerperium and perinatal conditions	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Anaemia of pregnancy	Blood and lymphatic system disorders	—	—
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Failed induction of labour	Pregnancy, puerperium and perinatal conditions	—	—
Intentional self-injury	Psychiatric disorders	—	—
Complication of pregnancy	Pregnancy, puerperium and perinatal conditions	—	—
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	—	—
Appendicitis	Infections and infestations	—	—
Intra-uterine death	Pregnancy, puerperium and perinatal conditions	—	—
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions	—	—
Obstructed labour	Pregnancy, puerperium and perinatal conditions	—	—

Other adverse events (30 terms — click to expand)

Reaction	System	Cervarix Group	Havrix Group
Pain	General disorders	—	—
Menstruation irregular	Reproductive system and breast disorders	—	—
Influenza	Infections and infestations	—	—
Vaginal infection	Infections and infestations	—	—
Headache	General disorders	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Redness	General disorders	—	—
Fatigue	General disorders	—	—
Fever	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Influenza	Infections and infestations	—	—
Gastrointestinal inflammation	Gastrointestinal disorders	—	—
Myalgia	General disorders	—	—
Myalgia	General disorders	—	—
Headache	General disorders	—	—
Headache	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Swelling	General disorders	—	—
Pain	General disorders	—	—
Gastrointestinal	General disorders	—	—
Dengue fever	Infections and infestations	—	—
Gastrointestinal	General disorders	—	—
Arthralgia	General disorders	—	—
Fever	General disorders	—	—
Rash	General disorders	—	—
Swelling	General disorders	—	—

Most-reported serious reactions: Abortion spontaneous incomplete, False labour, Abortion spontaneous complete, Foetal distress syndrome, Abortion missed, Caesarean section, Uterine hypotonus, Gestational hypertension.

Data from ClinicalTrials.gov NCT00128661 adverse events section.

Sponsor's own description

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.

PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.

Publications & conference data

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

1. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial.
   Hildesheim A, Herrero R, Wacholder S, Rodriguez AC, et al · · 2007 · cited 415× · PMID 17699008 · DOI 10.1001/jama.298.7.743
2. Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica.
   Herrero R, Quint W, Hildesheim A, Gonzalez P, et al · · 2013 · cited 333× · PMID 23873171 · DOI 10.1371/journal.pone.0068329
3. 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
4. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine.
   Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, et al · · 2011 · cited 236× · PMID 21908768 · DOI 10.1093/jnci/djr319
5. HPV16 E7 Genetic Conservation Is Critical to Carcinogenesis.
   Mirabello L, Yeager M, Yu K, Clifford GM, et al · · 2017 · cited 229× · PMID 28886384 · DOI 10.1016/j.cell.2017.08.001
6. Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA Trials.
   Kreimer AR, Struyf F, Del Rosario-Raymundo MR, Hildesheim A, et al · · 2015 · cited 227× · PMID 26071347 · DOI 10.1016/s1470-2045(15)00047-9
7. Cervicovaginal microbiome and natural history of HPV in a longitudinal study.
   Usyk M, Zolnik CP, Castle PE, Porras C, et al · · 2020 · cited 207× · PMID 32214382 · DOI 10.1371/journal.ppat.1008376
8. Virus-like particle vaccinology, from bench to bedside.
   Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8