Adults 18 to 25, 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 Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)Primary· At Month 7
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.
Anti-HPV-16
Group
Value
95% CI
Cervarix Lot1 Group
118
Cervarix Lot2 Group
127
Cervarix Lot3 Group
126
Pooled Group
371
Cervarix Low Group
102
Anti-HPV-18
Group
Value
95% CI
Cervarix Lot1 Group
129
Cervarix Lot2 Group
143
Cervarix Lot3 Group
135
Pooled Group
407
Cervarix Low Group
117
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18Primary· At Month 7
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Anti-HPV-16
Group
Value
95% CI
Cervarix Lot1 Group
54
Cervarix Lot2 Group
38
Cervarix Lot3 Group
43
Cervarix Low Group
57
Anti-HPV-18
Group
Value
95% CI
Cervarix Lot1 Group
43
Cervarix Lot2 Group
22
Cervarix Lot3 Group
34
Cervarix Low Group
41
Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18Secondary· At Month 2
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Anti-HPV-16
Group
Value
95% CI
Cervarix Lot1 Group
117
Cervarix Lot2 Group
126
Cervarix Lot3 Group
125
Cervarix Low Group
102
Anti-HPV-18
Group
Value
95% CI
Cervarix Lot1 Group
128
Cervarix Lot2 Group
142
Cervarix Lot3 Group
134
Cervarix Low Group
116
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18Secondary· At Month 2
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .
Anti-HPV-16
Group
Value
95% CI
Cervarix Lot1 Group
54
Cervarix Lot2 Group
38
Cervarix Lot3 Group
43
Cervarix Low Group
56
Anti-HPV-18
Group
Value
95% CI
Cervarix Lot1 Group
43
Cervarix Lot2 Group
22
Cervarix Lot3 Group
34
Cervarix Low Group
41
Number of Subjects With Any and Grade 3 Solicited Local SymptomsSecondary· During the 7-days (Day 0-6) post-vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.
Any Pain Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
188
Cervarix Lot2 Group
190
Cervarix Lot3 Group
178
Pooled Group
556
Cervarix Low Group
185
Grade 3 Pain Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
20
Cervarix Lot2 Group
16
Cervarix Lot3 Group
17
Pooled Group
53
Cervarix Low Group
12
Any Redness Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
74
Cervarix Lot2 Group
71
Cervarix Lot3 Group
77
Pooled Group
222
Cervarix Low Group
75
Grade 3 Redness Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
0
Pooled Group
0
Cervarix Low Group
0
Any Swelling Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
58
Cervarix Lot2 Group
57
Cervarix Lot3 Group
57
Pooled Group
172
Cervarix Low Group
54
Grade 3 Swelling Dose 1
Group
Value
95% CI
Cervarix Lot1 Group
9
Cervarix Lot2 Group
2
Cervarix Lot3 Group
2
Pooled Group
13
Cervarix Low Group
4
Any Pain Dose 2
Group
Value
95% CI
Cervarix Lot1 Group
167
Cervarix Lot2 Group
166
Cervarix Lot3 Group
170
Pooled Group
503
Cervarix Low Group
161
Grade 3 Pain Dose 2
Group
Value
95% CI
Cervarix Lot1 Group
17
Cervarix Lot2 Group
10
Cervarix Lot3 Group
19
Pooled Group
46
Cervarix Low Group
12
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsSecondary· During the 7-days (Day 0-6) post-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vac
Any Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
19
Cervarix Lot2 Group
19
Cervarix Lot3 Group
13
Pooled Group
51
Cervarix Low Group
17
Grade 3 Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
1
Cervarix Lot2 Group
0
Cervarix Lot3 Group
2
Pooled Group
3
Cervarix Low Group
0
Related Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
14
Cervarix Lot2 Group
17
Cervarix Lot3 Group
8
Pooled Group
39
Cervarix Low Group
14
Any Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
81
Cervarix Lot2 Group
84
Cervarix Lot3 Group
73
Pooled Group
238
Cervarix Low Group
80
Grade 3 Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
4
Cervarix Lot2 Group
1
Cervarix Lot3 Group
4
Pooled Group
9
Cervarix Low Group
5
Related Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
60
Cervarix Lot2 Group
62
Cervarix Lot3 Group
48
Pooled Group
170
Cervarix Low Group
61
Any Fever
Group
Value
95% CI
Cervarix Lot1 Group
4
Cervarix Lot2 Group
7
Cervarix Lot3 Group
4
Pooled Group
15
Cervarix Low Group
5
Grade 3 Fever
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
0
Pooled Group
0
Cervarix Low Group
0
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsSecondary· During the 7-days (Day 0-6) post-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vac
Any Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
14
Cervarix Lot2 Group
14
Cervarix Lot3 Group
14
Pooled Group
42
Cervarix Low Group
17
Grade 3 Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
1
Pooled Group
1
Cervarix Low Group
0
Related Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
12
Cervarix Lot2 Group
11
Cervarix Lot3 Group
10
Pooled Group
33
Cervarix Low Group
14
Any Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
63
Cervarix Lot2 Group
73
Cervarix Lot3 Group
69
Pooled Group
205
Cervarix Low Group
58
Grade 3 Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
2
Cervarix Lot2 Group
4
Cervarix Lot3 Group
3
Pooled Group
9
Cervarix Low Group
5
Related Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
39
Cervarix Lot2 Group
55
Cervarix Lot3 Group
38
Pooled Group
132
Cervarix Low Group
40
Any Fever
Group
Value
95% CI
Cervarix Lot1 Group
7
Cervarix Lot2 Group
5
Cervarix Lot3 Group
7
Pooled Group
19
Cervarix Low Group
5
Grade 3 Fever
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
0
Pooled Group
0
Cervarix Low Group
0
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsSecondary· During the 7-days (Day 0-6) post-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vac
Any Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
18
Cervarix Lot2 Group
19
Cervarix Lot3 Group
18
Pooled Group
55
Cervarix Low Group
13
Grade 3 Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
1
Cervarix Lot2 Group
1
Cervarix Lot3 Group
0
Pooled Group
2
Cervarix Low Group
0
Related Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
15
Cervarix Lot2 Group
16
Cervarix Lot3 Group
12
Pooled Group
43
Cervarix Low Group
11
Any Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
76
Cervarix Lot2 Group
67
Cervarix Lot3 Group
64
Pooled Group
207
Cervarix Low Group
60
Grade 3 Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
9
Cervarix Lot2 Group
1
Cervarix Lot3 Group
2
Pooled Group
12
Cervarix Low Group
6
Related Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
58
Cervarix Lot2 Group
50
Cervarix Lot3 Group
49
Pooled Group
157
Cervarix Low Group
49
Any Fever
Group
Value
95% CI
Cervarix Lot1 Group
7
Cervarix Lot2 Group
6
Cervarix Lot3 Group
4
Pooled Group
17
Cervarix Low Group
8
Grade 3 Fever
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
1
Pooled Group
1
Cervarix Low Group
0
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsSecondary· During the 7-days (Day 0-6) post-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicite
Any Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
38
Cervarix Lot2 Group
40
Cervarix Lot3 Group
32
Pooled Group
110
Cervarix Low Group
35
Grade 3 Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
2
Cervarix Lot2 Group
1
Cervarix Lot3 Group
2
Pooled Group
5
Cervarix Low Group
0
Related Arthralgia
Group
Value
95% CI
Cervarix Lot1 Group
31
Cervarix Lot2 Group
32
Cervarix Lot3 Group
22
Pooled Group
85
Cervarix Low Group
31
Any Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
117
Cervarix Lot2 Group
117
Cervarix Lot3 Group
106
Pooled Group
340
Cervarix Low Group
105
Grade 3 Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
13
Cervarix Lot2 Group
6
Cervarix Lot3 Group
8
Pooled Group
27
Cervarix Low Group
12
Related Fatigue
Group
Value
95% CI
Cervarix Lot1 Group
90
Cervarix Lot2 Group
95
Cervarix Lot3 Group
78
Pooled Group
263
Cervarix Low Group
90
Any Fever
Group
Value
95% CI
Cervarix Lot1 Group
16
Cervarix Lot2 Group
18
Cervarix Lot3 Group
14
Pooled Group
48
Cervarix Low Group
15
Grade 3 Fever
Group
Value
95% CI
Cervarix Lot1 Group
0
Cervarix Lot2 Group
0
Cervarix Lot3 Group
1
Pooled Group
1
Cervarix Low Group
0
Number of Subjects With New Onset Chronic Diseases (NOCDs)Secondary· From Month 0 to Month 7
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Group
Value
95% CI
Cervarix Lot1 Group
3
Cervarix Lot2 Group
4
Cervarix Lot3 Group
7
Pooled Group
14
Cervarix Low Group
3
Number of Subjects With Medically Significant Adverse Events (MSAEs)Secondary· From Month 0 to Month 7
MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Group
Value
95% CI
Pooled Group
71
Cervarix Low Group
23
Number of Subjects With (NOCDs)Secondary· From Month 0 to Month 12
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Group
Value
95% CI
Cervarix Lot1 Group
4
Cervarix Lot2 Group
4
Cervarix Lot3 Group
7
Pooled Group
15
Cervarix Low Group
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12)..
Reporting threshold: 4.9%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT00546078 — Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
· Phase 2
· completed
NCT00578227 — Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy
· 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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Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT00250276.