A Phase 2 interventional study of CervarixTM and HPV investigational vaccine GSK568893A, different formulations in Infections, Papillomavirus and Papillomavirus Vaccines, sponsored by GlaxoSmithKline. Completed at 10 sites in 2 countries. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: CervarixTM
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV vaccine
Subjects were administered three doses of HPV investigational vaccine
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Time frame: At Months 18, 24, 36 and 48.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.
Time frame: From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
Time frame: From Month 0 to Month 18
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
Time frame: From Month 0 to Month 24
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
Time frame: From Month 0 to Month 36
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
Time frame: From Month 0 to Month 48
The study is a safety follow-up of the primary study NCT00231413, starting from Month 18 post-vaccination.
| Milestone | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Started | 88 | 50 | 49 | 48 | 48 | 50 | 50 |
| Completed | 80 | 45 | 42 | 45 | 45 | 45 | 46 |
| Not completed | 8 | 5 | 7 | 3 | 3 | 5 | 4 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 | 4 | 2 | 2 | 0 | 3 |
| Withdrew: Other | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 4 | 4 | 2 | 1 | 1 | 5 | 0 |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13) | 27 | 10 | 9 | 8 | 14 | 13 | 13 |
| Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15) | 28 | 12 | 11 | 9 | 16 | 15 | 15 |
| Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15) | 28 | 12 | 11 | 9 | 16 | 15 | 15 |
| Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15) | 28 | 12 | 11 | 9 | 16 | 15 | 15 |
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
| EL.U/mL | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13) | 1933.9 (1318.0 to 2837.5) | 1868.3 (1263.0 to 2763.8) | 1902.3 (603.5 to 5996.7) | 1996.4 (1017.8 to 3915.8) | 1437.1 (777.3 to 2657.0) | 2200.3 (1284.4 to 3769.4) | 1769.8 (914.9 to 3423.7) |
| Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15) | 1477.1 (1039.3 to 2099.3) | 1381.6 (942.1 to 2026.4) | 1339.9 (553.1 to 3246.1) | 1520.6 (916.6 to 2522.5) | 1264.4 (718.8 to 2224.0) | 1817.8 (1194.5 to 2766.4) | 1585.6 (952.0 to 2640.9) |
| Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15) | 1296.8 (917.1 to 1833.6) | 1200.5 (814.8 to 1768.9) | 1023.1 (389.2 to 2689.8) | 1275.3 (780.2 to 2084.7) | 960.6 (555.6 to 1660.7) | 1521.8 (943.4 to 2454.8) | 1076.9 (619.0 to 1873.6) |
| Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15) | 1300.9 (952.3 to 1777.1) | 1115.4 (780.3 to 1594.3) | 1007.5 (361.3 to 2809.6) | 1337.7 (755.4 to 2368.9) | 1070.8 (614.6 to 1865.7) | 1417.8 (882.0 to 2279.0) | 1105.5 (620.6 to 1969.3) |
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
| Titers | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17) | 1902.6 (1309.3 to 2764.7) | 1558.5 (1122.9 to 2163.2) | 1791.7 (823.6 to 3897.7) | 1552.9 (981.6 to 2456.5) | 1242.8 (687.3 to 2247.4) | 1869.6 (1161.1 to 3010.5) | 1764.4 (1073.8 to 2899.2) |
| Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19) | 1472.8 (1046.2 to 2073.3) | 1223.4 (911.2 to 1642.6) | 1347.4 (740.7 to 2451.1) | 1579.5 (1053.9 to 2367.2) | 1092.8 (626.2 to 1907.2) | 1672.2 (1130.2 to 2474.1) | 1130.2 (1130.2 to 2367.2) |
| Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19) | 1291.7 (928.4 to 1797.1) | 1031.2 (764.2 to 1391.5) | 1032.9 (538.9 to 1979.5) | 1107.7 (776.4 to 1580.3) | 841.4 (495.4 to 1428.9) | 1381.9 (901.0 to 2119.3) | 1128.6 (728.5 to 1748.3) |
| Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19) | 1248.8 (907.1 to 1719.1) | 955.5 (722.7 to 1263.1) | 1104.9 (556.9 to 2192.1) | 1097.4 (737.8 to 1632.4) | 911.3 (526.5 to 1577.4) | 1310.1 (862.8 to 1989.2) | 1150.4 (727.8 to 1818.3) |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15) | 26 | 10 | 12 | 16 | 11 | 15 | 15 |
| Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17) | 26 | 13 | 14 | 18 | 12 | 18 | 17 |
| Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17) | 26 | 13 | 14 | 18 | 12 | 18 | 17 |
| Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17) | 26 | 13 | 14 | 18 | 12 | 18 | 17 |
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
| EL.U/mL | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15) | 1060.9 (720.1 to 1562.9) | 469.3 (247.6 to 889.4) | 532.5 (211.2 to 1342.7) | 536.7 (296.0 to 973.0) | 563.7 (262.0 to 1212.5) | 637.9 (394.8 to 1030.8) | 572.2 (342.7 to 955.3) |
| Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17) | 781.7 (538.5 to 1134.9) | 321.2 (192.8 to 535.2) | 387.0 (185.7 to 806.6) | 465.1 (267.6 to 808.5) | 502.4 (225.1 to 1121.5) | 536.5 (358.9 to 802.0) | 419.7 (269.1 to 654.5) |
| Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17) | 733.6 (487.2 to 1104.6) | 286.1 (179.4 to 456.1) | 333.4 (151.0 to 736.0) | 424.6 (254.4 to 708.5) | 381.7 (165.1 to 882.7) | 456.5 (299.8 to 695.2) | 356.7 (232.3 to 547.8) |
| Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17) | 729.3 (516.0 to 1030.8) | 248.6 (149.7 to 412.8) | 278.3 (125.6 to 616.6) | 443.3 (252.6 to 778.0) | 382.0 (170.8 to 854.0) | 440.7 (290.2 to 669.2) | 320.9 (206.2 to 499.2) |
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
| Titers | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17) | 994.4 (699.5 to 1413.5) | 525.5 (328.2 to 841.6) | 524.1 (225.6 to 1217.5) | 536.7 (296.0 to 973.0) | 551.1 (312.4 to 972.2) | 574.9 (355.3 to 930.2) | 570.5 (365.6 to 890.4) |
| Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19) | 739.5 (526.6 to 1038.3) | 355.2 (236.2 to 534.3) | 410.5 (217.0 to 776.6) | 465.1 (267.6 to 808.5) | 442.1 (251.9 to 775.8) | 497.7 (329.4 to 752.1) | 425.4 (287.1 to 630.5) |
| Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19) | 683.5 (475.4 to 982.7) | 320.5 (220.4 to 466.1) | 349.8 (175.7 to 696.5) | 424.6 (254.4 to 708.5) | 348.1 (193.0 to 628.1) | 426.1 (281.7 to 644.4) | 364.9 (249.2 to 534.4) |
| Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19) | 666.3 (477.9 to 929.2) | 284.6 (190.8 to 424.7) | 297.7 (148.9 to 595.3) | 443.3 (252.6 to 778.0) | 329.7 (184.8 to 588.2) | 412.0 (273.3 to 621.0) | 330.2 (222.3 to 490.4) |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17) | 25 | 13 | 12 | 13 | 14 | 15 | 17 |
| Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19) | 22 | 16 | 15 | 15 | 16 | 17 | 19 |
| Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19) | 23 | 16 | 15 | 15 | 16 | 18 | 19 |
| Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19) | 23 | 16 | 15 | 15 | 16 | 18 | 19 |
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
| EL.U/mL. | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17) | 187.7 (124.2 to 283.8) | 1776.8 (1086.4 to 2906.1) | 2685.9 (1157.8 to 6230.9) | 2388.8 (1352.0 to 4220.8) | 2714.9 (1312.1 to 5617.3) | 1952.4 (1226.4 to 3108.2) | 3466.4 (2077.8 to 5782.9) |
| Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19) | 125.3 (80.6 to 194.8) | 1336.1 (891.6 to 2002.2) | 2076.2 (1168.0 to 3690.7) | 1966.7 (1221.9 to 3165.5) | 2298.0 (1214.8 to 4347.0) | 1911.8 (1162.0 to 3145.5) | 2518.3 (1648.7 to 3846.7) |
| Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19) | 164.6 (107.7 to 251.7) | 1346.7 (941.1 to 1927.0) | 1776.6 (976.5 to 3232.1) | 1644.0 (993.6 to 2720.2) | 1825.1 (984.1 to 3384.7) | 1584.1 (982.1 to 2555.2) | 2080.0 (1400.9 to 3088.3) |
| Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19) | 174.7 (114.4 to 266.7) | 1284.5 (878.4 to 1878.3) | 2105.3 (1155.1 to 3837.3) | 1744.2 (966.3 to 3148.3) | 2126.9 (1159.6 to 3901.1) | 1434.2 (892.0 to 2306.0) | 2118.1 (1536.6 to 2919.7) |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15) | 20 | 14 | 10 | 11 | 14 | 15 | 15 |
| Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16) | 19 | 17 | 12 | 13 | 16 | 17 | 16 |
| Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16) | 18 | 17 | 12 | 13 | 16 | 18 | 16 |
| Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16) | 19 | 17 | 12 | 13 | 16 | 18 | 16 |
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
| EL.U/mL | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15) | 184.8 (111.9 to 305.1) | 919.8 (510.9 to 1655.9) | 1731.0 (591.8 to 5063.3) | 959.1 (557.9 to 1648.9) | 1086.6 (528.7 to 2233.2) | 1235.8 (757.9 to 2014.8) | 1094.9 (613.1 to 1955.4) |
| Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16) | 138.3 (86.4 to 221.4) | 713.0 (440.6 to 1153.9) | 1274.5 (590.1 to 2752.5) | 904.9 (546.7 to 1497.8) | 948.1 (515.2 to 1744.6) | 1106.5 (680.1 to 1800.4) | 848.2 (494.1 to 1456.0) |
| Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16) | 165.4 (97.9 to 279.4) | 707.8 (451.9 to 1108.6) | 1103.9 (521.0 to 2338.8) | 810.7 (492.6 to 1334.2) | 825.2 (450.2 to 1512.4) | 1015.6 (660.2 to 1562.4) | 774.7 (486.2 to 1234.3) |
| Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16) | 190.7 (115.8 to 314.1) | 659.0 (415.4 to 1045.6) | 1036.2 (477.2 to 2249.9) | 806.9 (447.5 to 1454.7) | 815.1 (453.3 to 1465.7) | 914.6 (600.7 to 1392.5) | 750.0 (448.0 to 1255.5) |
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| NOCD(s) at Month 18 | 6 | 1 | 6 | 2 | 3 | 1 | 2 |
| NOCD(s) at Month 24 | 6 | 1 | 6 | 2 | 3 | 1 | 2 |
| NOCD(s) at Month 36 | 7 | 1 | 6 | 2 | 3 | 1 | 3 |
| NOCD(s) at Month 48 | 7 | 1 | 7 | 3 | 4 | 1 | 4 |
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| MAE(s) at Month 18 | 4 | 3 | 2 | 4 | 5 | 1 | 1 |
| MAE(s) at Month 24 | 6 | 3 | 3 | 7 | 8 | 5 | 1 |
| MAE(s) at Month 36 | 9 | 4 | 3 | 7 | 9 | 5 | 2 |
| MAE(s) at Month 48 | 14 | 7 | 5 | 9 | 12 | 5 | 3 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Any SAE(s) at Month 18 | 2 | 3 | 1 | 3 | 2 | 0 | 1 |
| Any SAE(s) at Month 24 | 2 | 3 | 1 | 3 | 3 | 1 | 1 |
| Any SAE(s) at Month 36 | 2 | 3 | 2 | 4 | 3 | 1 | 1 |
| Any SAE(s) at Month 48 | 6 | 4 | 2 | 6 | 3 | 1 | 1 |
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Healthy baby | 3 | 0 | 2 | 1 | 0 | 1 | 3 |
| Spontaneous abortion | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Elective abortion | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Healthy baby | 4 | 1 | 2 | 2 | 0 | 1 | 3 |
| Spontaneous abortion | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Elective abortion | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ongoing pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Healthy baby | 4 | 4 | 3 | 2 | 0 | 1 | 3 |
| Abnormal infant/congenital anomaly | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Spontaneous abortion | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Elective abortion | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
| subjects | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| Normal infant | 9 | 6 | 3 | 2 | 0 | 1 | 4 |
| Abnormal infant/congenital anomaly | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Spontaneous abortion | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Elective termination | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
Collected over SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix Group | — | 6/88 (6.8%) | — |
| Cervarix 1 Group | — | 4/50 (8%) | — |
| Cervarix 2 Group | — | 2/49 (4.1%) | — |
| Cervarix 3 Group | — | 6/48 (12.5%) | — |
| Cervarix 4 Group | — | 3/48 (6.3%) | — |
| Cervarix 5 Group | — | 1/50 (2%) | — |
| Cervarix 6 Group | — | 1/50 (2%) | — |
| Event | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group |
|---|---|---|---|---|---|---|---|
| AppendicitisInfections and infestations | 1/88 | 1/50 | 1/49 | 1/48 | 1/48 | 0/50 | 0/50 |
| CellulitisInfections and infestations | 0/88 | 0/50 | 0/49 | 0/48 | 1/48 | 0/50 | 0/50 |
| Tonsillitis streptococcalInfections and infestations | 0/88 | 0/50 | 0/49 | 1/48 | 0/48 | 0/50 | 0/50 |
| MyelitisNervous system disorders | 0/88 | 0/50 | 0/49 | 1/48 | 0/48 | 0/50 | 0/50 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/88 | 0/50 | 0/49 | 0/48 | 1/48 | 0/50 | 0/50 |
| Abortion spontaneous completePregnancy, puerperium and perinatal conditions | 0/88 | 0/50 | 0/49 | 1/48 | 0/48 | 0/50 | 0/50 |
| Bulimia nervosaPsychiatric disorders | 0/88 | 0/50 | 0/49 | 1/48 | 0/48 | 0/50 | 0/50 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/88 | 0/50 | 0/49 | 1/48 | 0/48 | 0/50 | 0/50 |
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 0/88 | 0/50 | 1/49 | 0/48 | 0/48 | 0/50 | 0/50 |
| Premature labourPregnancy, puerperium and perinatal conditions | 0/88 | 0/50 | 1/49 | 0/48 | 0/48 | 0/50 | 0/50 |
| Age, Continuous(Years) | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 20.9 ± 2.03 | 21.5 ± 2.18 | 21.2 ± 2.07 | 21.1 ± 2.09 | 21.4 ± 2.27 | 21.2 ± 2.26 | 20.7 ± 1.91 | 21.1 ± 2.11 |
| Sex: Female, Male(Participants) | Cervarix Group | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Cervarix 4 Group | Cervarix 5 Group | Cervarix 6 Group | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 88 | 50 | 49 | 48 | 48 | 50 | 50 | 383 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting information: Study protocol, Icf, Csr
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