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Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

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ClinicalTrials.gov Identifier: NCT00337818
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : March 2, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Papillomavirus Type 16/18 Infection
Cervical Intraepithelial Neoplasia
Intervention Biological: Cervarix™
Enrollment 770
Recruitment Details  
Pre-assignment Details Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Period Title: Overall Study
Started 458 154 158
Completed 169 63 51
Not Completed 289 91 107
Reason Not Completed
Lost to Follow-up             289             91             107
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young Total
Hide Arm/Group Description Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. Total of all reporting groups
Overall Number of Baseline Participants 458 154 158 770
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 458 participants 154 participants 158 participants 770 participants
20.2  (2.96) 20.3  (2.99) 12.4  (1.37) 18.6  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 458 participants 154 participants 158 participants 770 participants
Female
458
 100.0%
154
 100.0%
158
 100.0%
770
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description:
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Overall Number of Participants Analyzed 160 51 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
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)
2.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame At months 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description:
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Overall Number of Participants Analyzed 78 27 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
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)
3.Secondary Outcome
Title Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame At Months 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description:
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Overall Number of Participants Analyzed 78 27 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
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)
4.Secondary Outcome
Title Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description:
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Overall Number of Participants Analyzed 186 65 57
Measure Type: Number
Unit of Measure: Subjects
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
5.Secondary Outcome
Title Number of Subjects Reporting SAEs
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort of each time point.
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description:
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Overall Number of Participants Analyzed 186 65 57
Measure Type: Number
Unit of Measure: Subjects
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
Time Frame During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Adverse Event Reporting Description

Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.

The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.

 
Arm/Group Title Cervarix New Process Cervarix Old Process Group Cervarix Young
Hide Arm/Group Description Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
All-Cause Mortality
Cervarix New Process Cervarix Old Process Group Cervarix Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cervarix New Process Cervarix Old Process Group Cervarix Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/186 (5.91%)   3/65 (4.62%)   3/57 (5.26%) 
Gastrointestinal disorders       
Abdominal pain *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
Diarrhoea *  1/169 (0.59%)  0/63 (0.00%)  0/51 (0.00%) 
Infections and infestations       
Anogenital warts *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
Enteritis infectious *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
Genital herpes *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
Osteomyelitis *  0/186 (0.00%)  0/65 (0.00%)  1/57 (1.75%) 
Enterocolitis infectious *  1/169 (0.59%)  0/63 (0.00%)  0/51 (0.00%) 
Pyelonephritis *  0/186 (0.00%)  1/64 (1.56%)  0/57 (0.00%) 
Injury, poisoning and procedural complications       
Overdose *  0/186 (0.00%)  0/65 (0.00%)  1/57 (1.75%) 
Road traffic accident *  0/186 (0.00%)  0/65 (0.00%)  1/57 (1.75%) 
Pregnancy, puerperium and perinatal conditions       
Blighted ovum *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
Abortion spontaneous *  0/169 (0.00%)  2/63 (3.17%)  0/51 (0.00%) 
Chorioamnionitis *  1/169 (0.59%)  0/63 (0.00%)  0/51 (0.00%) 
Stillbirth *  1/169 (0.59%)  0/63 (0.00%)  0/51 (0.00%) 
Premature separation of placenta *  1/186 (0.54%)  0/64 (0.00%)  0/57 (0.00%) 
Reproductive system and breast disorders       
Endometriosis *  2/186 (1.08%)  0/65 (0.00%)  0/57 (0.00%) 
Ovarian cyst *  1/186 (0.54%)  0/64 (0.00%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis *  1/186 (0.54%)  0/65 (0.00%)  0/57 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix New Process Cervarix Old Process Group Cervarix Young
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00337818    
Obsolete Identifiers: NCT00337844, NCT00337857, NCT00338169
Other Study ID Numbers: 107476 (M18)
107477 ( Other Identifier: GSK )
107479 ( Other Identifier: GSK )
107481 ( Other Identifier: GSK )
First Submitted: June 15, 2006
First Posted: June 16, 2006
Results First Submitted: November 12, 2009
Results First Posted: March 2, 2010
Last Update Posted: May 30, 2017