A Phase 3 interventional study of Cervarix™ in Papillomavirus Type 16/18 Infection and Cervical Intraepithelial Neoplasia, sponsored by GlaxoSmithKline. Completed at 1 site in Estonia. Open to female participants aged 10 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 770 is above the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
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Exclusion criteria
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the new manufacturing process.
Biological: Cervarix™
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the old manufacturing process.
Biological: Cervarix™
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\]) produced with the new manufacturing process (Lot 1).
Biological: Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Time frame: At months 18*, 24, 36 and 48
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At months 24, 36, and 48
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time frame: At Months 24, 36 and 48
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Time frame: Throughout the study period (up to Month 48)
Number of Subjects Reporting 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.
Time frame: Throughout the study period (up to Month 48)
| Milestone | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| Started | 458 | 154 | 158 |
| Completed | 169 | 63 | 51 |
| Not completed | 289 | 91 | 107 |
| Withdrew: Lost to follow-up | 289 | 91 | 107 |
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
| EL.U/mL | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| Anti-HPV-16 (Month 24) (n=160, 51, 55) | 1440.4 (1249.3 to 1660.7) | 1903.7 (1396.0 to 2596.0) | 3861.7 (2947.0 to 5060.4) |
| Anti-HPV-16 (Month 36) (n=150, 46, 52) | 1397.5 (1207.1 to 1618.1) | 1679.3 (1211.5 to 2327.6) | 3353.0 (2553.4 to 4403.1) |
| Anti-HPV-16 (Month 48) (n=141, 49, 49) | 1140.9 (974.9 to 1335.3) | 1427.3 (1027.6 to 1982.4) | 2862.2 (2129.3 to 3847.3) |
| Anti-HPV-18 (Month 24) (n=160, 50, 54) | 649.8 (554.3 to 761.8) | 778.8 (577.1 to 1050.8) | 1341.8 (1053.2 to 1709.6) |
| Anti-HPV-18 (Month 36) (n=151, 45, 51) | 574.7 (490.2 to 673.7) | 649.6 (464.5 to 908.4) | 1111.0 (848.5 to 1454.9) |
| Anti-HPV-18 (Month 48) (n=141, 48, 48) | 462.4 (391.5 to 546.1) | 519.9 (374.1 to 722.4) | 935.6 (717.9 to 1219.5) |
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
| EL.U/mL | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| HPV-16 (Month 24) (n= 55, 13, 1) | 85.4 (57.9 to 125.8) | 107.5 (47.5 to 242.8) | 198.8 (198.8 to 198.8) |
| HPV-16 (Month 36) (n= 78, 27, 3) | 68.2 (54.6 to 85.2) | 62.1 (40.8 to 94.7) | 63.4 (4.8 to 845.9) |
| HPV-16 (Month 48) (n=69, 19, 4) | 56.2 (43.4 to 72.8) | 94.5 (50.8 to 175.8) | 129.2 (12.8 to 1305.0) |
| HPV-18 (Month 24) (n= 55, 13, 1) | 45.9 (31.1 to 67.6) | 31.9 (15.8 to 64.4) | 107.9 (107.9 to 107.9) |
| HPV-18 (Month 36) (n= 78, 27, 3) | 38.9 (31.2 to 48.6) | 29.6 (19.8 to 44.2) | 19.9 (1.1 to 362.2) |
| HPV-18 (Month 48) (n= 66, 19, 4) | 33.9 (24.7 to 46.5) | 48.8 (26.4 to 90.0) | 97.5 (38.7 to 245.4) |
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
| EL.U/mL | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| Anti-HPV-16 [Month 24] (n=74;24;3) | 1403.1 (1126.9 to 1747.0) | 1490.5 (1016.1 to 2186.5) | 5399.5 (367.9 to 79243.9) |
| Anti-HPV-16 [Month 36] (n=78;27;3) | 1291.8 (1030.9 to 1618.7) | 1435.0 (993.0 to 2073.8) | 3733.3 (383.1 to 36384.7) |
| Anti-HPV-16 [Month 48] (n=69;19;4) | 1047.3 (854.2 to 1284.0) | 1950.5 (1095.1 to 3474.1) | 3332.7 (1087.6 to 10212.5) |
| Anti-HPV-18 [Month 24] (n=74;24;3) | 584.5 (461.1 to 741.0) | 648.6 (467.7 to 899.6) | 1814.6 (240.3 to 13702.9) |
| Anti-HPV-18 [Month 36] (n=78;27;3) | 555.4 (439.3 to 702.1) | 542.1 (392.8 to 748.0) | 1163.6 (88.8 to 15244.0) |
| Anti-HPV-18 [Month 48] (n=66;19;4) | 478.4 (376.8 to 607.3) | 805.4 (491.2 to 1320.5) | 1048.9 (250.5 to 4392.8) |
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
| Subjects | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| NOCDs from Month 12 to Month 24 (n= 186, 64, 57) | 1 | 0 | 1 |
| NOCDs from Month 24 to Month 36 (n= 184, 65, 53) | 3 | 0 | 1 |
| NOCDs from Month 36 to Month 48 (n= 169, 63, 51) | 0 | 1 | 1 |
| MSCs from Month 12 to Month 24 (n= 186, 64, 57) | 12 | 4 | 2 |
| MSCs from Month 24 to Month 36 (n= 184, 65, 53) | 35 | 10 | 6 |
| MSCs from Month 36 to Month 48 (n= 169, 63, 51) | 19 | 5 | 1 |
| Pregnancies from Month 12 to Month 24(n=186,64,57) | 4 | 2 | 0 |
| Pregnancies from Month 24 to Month 36(n=184,65,53) | 20 | 7 | 0 |
| Pregnancies from Month 36 to Month 48(n=169,63,51) | 15 | 6 | 1 |
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.
| Subjects | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| From Month 12 to 24 (n=186,64,57) | 2 | 1 | 0 |
| From Month 24 to 36 (n=184,65,53) | 7 | 0 | 3 |
| From Month 36 to 48 (n=169,63,51) | 5 | 2 | 0 |
Collected over During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix New Process | — | 11/186 (5.9%) | — |
| Cervarix Old Process Group | — | 3/65 (4.6%) | — |
| Cervarix Young | — | 3/57 (5.3%) | — |
| Event | Cervarix New Process | Cervarix Old Process Group | Cervarix Young |
|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/169 | 2/63 | 0/51 |
| OsteomyelitisInfections and infestations | 0/186 | 0/65 | 1/57 |
| OverdoseInjury, poisoning and procedural complications | 0/186 | 0/65 | 1/57 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/186 | 0/65 | 1/57 |
| PyelonephritisInfections and infestations | 0/186 | 1/64 | 0/57 |
| EndometriosisReproductive system and breast disorders | 2/186 | 0/65 | 0/57 |
| ChorioamnionitisPregnancy, puerperium and perinatal conditions | 1/169 | 0/63 | 0/51 |
| DiarrhoeaGastrointestinal disorders | 1/169 | 0/63 | 0/51 |
| Enterocolitis infectiousInfections and infestations | 1/169 | 0/63 | 0/51 |
| StillbirthPregnancy, puerperium and perinatal conditions | 1/169 | 0/63 | 0/51 |
| Age, Continuous(years) | Cervarix New Process | Cervarix Old Process Group | Cervarix Young | Total |
|---|---|---|---|---|
| Mean | 20.2 ± 2.96 | 20.3 ± 2.99 | 12.4 ± 1.37 | 18.6 ± 4.2 |
| Sex: Female, Male(Participants) | Cervarix New Process | Cervarix Old Process Group | Cervarix Young | Total |
|---|---|---|---|---|
| Female | 458 | 154 | 158 | 770 |
| Male | 0 | 0 | 0 | 0 |
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