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Trial record 69 of 91 for:    cervarix

Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

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ClinicalTrials.gov Identifier: NCT00929526
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : October 15, 2012
Last Update Posted : October 20, 2016
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
Condition Infections, Papillomavirus
Interventions Procedure: Liquid-based cytology (LBC) sampling
Procedure: Blood sampling
Enrollment 752
Recruitment Details No vaccines were administered in this extension study. The mean duration of this study was aproximately 12 months for each subjects (from Month 0 up to Month 12). This study began 36 months after the first vaccination in study NCT00316693.
Pre-assignment Details Subjects were randomised in the primary vaccination study NCT00316693 to receive the Cervarix vaccine or the Aimmugen vaccine and were aged 20 - 25 years at the time of first vaccination. Only subjects showing willingness to participate in this long term follow-up study and who had signed the informed consent form entered this study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Period Title: Overall Study
Started 375 377
Completed 358 348
Not Completed 17 29
Reason Not Completed
Withdrawal by Subject             1             11
Lost to Follow-up             8             12
Other             8             6
Arm/Group Title Cervarix Group Aimmugen Group Total
Hide Arm/Group Description subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693. Total of all reporting groups
Overall Number of Baseline Participants 375 377 752
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 375 participants 377 participants 752 participants
25.4  (1.72) 25.5  (1.72) 25.5  (1.72)
[1]
Measure Description: Japanase women aged 20 to 25 years at the time of first vaccination in the primary study NCT00316693
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Female
375
 100.0%
377
 100.0%
752
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.
Hide Description

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).

Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).

For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 332 335
Measure Type: Number
Unit of Measure: Subjects
CIN1+ HPV-16/18 (N=332;335) 0 5
CIN1+ HPV-16 (N=286;289) 0 5
CIN1+ HPV-18 (N=294;291) 0 0
2.Secondary Outcome
Title Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
Hide Description

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 332 335
Measure Type: Number
Unit of Measure: Subjects
ASC-US+ HPV-16/18 (N=332;335) 3 11
ASC-US+ HPV-16 (N=286;289) 2 10
ASC-US+ HPV-18 (N=294;291) 1 2
3.Secondary Outcome
Title Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.
Hide Description

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.

HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 363 359
Measure Type: Number
Unit of Measure: Subjects
33 45
4.Secondary Outcome
Title Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.
Hide Description

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 363 359
Measure Type: Number
Unit of Measure: Subjects
8 22
5.Secondary Outcome
Title Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
Hide Description

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 332 335
Measure Type: Number
Unit of Measure: Subjects
Incident infection HPV-16/18 (N=332;335) 7 28
Incident infection HPV-16 (N=286;289) 3 16
Incident infection HPV-18 (N=294;291) 5 13
6.Secondary Outcome
Title Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.
Hide Description HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 363 359
Measure Type: Number
Unit of Measure: Subjects
87 98
7.Secondary Outcome
Title Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.
Hide Description

Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 257 241
Measure Type: Number
Unit of Measure: Subjects
Persistent infection HPV-16/18 (N=257;241) 0 9
Persistent infection HPV-16 (N=225;206) 0 6
Persistent infection HPV-18 (N=227;209) 0 4
8.Secondary Outcome
Title Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.
Hide Description

Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Time Frame From Month 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 280 261
Measure Type: Number
Unit of Measure: Subjects
19 31
9.Secondary Outcome
Title Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
Hide Description Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.
Time Frame At Month 0 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 291 0
Measure Type: Number
Unit of Measure: Subjects
HPV-16 >=8 EL.U/mL [at Month 0] (N=282) 282
HPV-16 >=8 EL.U/mL [at Month 12] (N=291) 291
HPV-18 >=7 EL.U/mL [at Month 0] (N=281) 281
HPV-18 >=7 EL.U/mL [at Month 12] (N=290) 290
10.Secondary Outcome
Title HPV-16 and HPV-18 Antibody Titers
Hide Description Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.
Time Frame At Month 0 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 291 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
HPV-16 [Month 0] (N=282)
1409.9
(1268.1 to 1567.6)
HPV-16 [Month 12] (N=291)
1294.8
(1171.4 to 1431.1)
HPV-18 [Month 0] (N=281)
572.3
(505.6 to 647.7)
HPV-18 [Month 12] (N=290)
470.9
(419.2 to 528.9)
11.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 375 377
Measure Type: Number
Unit of Measure: Subjects
11 16
12.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.
Hide Description NOCDs included autoimmune diseases, diabetes mellitus.
Time Frame During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 375 377
Measure Type: Number
Unit of Measure: Subjects
2 2
13.Secondary Outcome
Title Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.
Hide Description [Not Specified]
Time Frame During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 375 377
Measure Type: Number
Unit of Measure: Subjects
2 1
14.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs).
Hide Description MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.
Time Frame During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 375 377
Measure Type: Number
Unit of Measure: Subjects
11 15
15.Secondary Outcome
Title Number of Subjects With Pregnancies and Pregnancy Outcomes.
Hide Description Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Time Frame During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Overall Number of Participants Analyzed 37 41
Measure Type: Number
Unit of Measure: Subjects
Live infant No ACA 28 30
Live infant CA 0 1
Elective termination No ACA 4 3
Spontaneous abortion No ACA 3 4
Stillbirth No ACA 1 0
Ectopic pregnancy 0 1
Lost to follow-up 0 2
Pregnancy ongoing 1 0
Time Frame SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
Adverse Event Reporting Description The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
 
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
All-Cause Mortality
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/375 (2.93%)   16/377 (4.24%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation *  1/375 (0.27%)  0/377 (0.00%) 
Congenital, familial and genetic disorders     
Ventricular septal defect *  0/375 (0.00%)  1/377 (0.27%) 
Hepatobiliary disorders     
Cholelithiasis *  0/375 (0.00%)  1/377 (0.27%) 
Infections and infestations     
Appendicitis *  0/375 (0.00%)  1/377 (0.27%) 
Mastitis *  0/375 (0.00%)  1/377 (0.27%) 
Pneumonia influenzal *  0/375 (0.00%)  1/377 (0.27%) 
Pneumonia mycoplasmal *  0/375 (0.00%)  1/377 (0.27%) 
Investigations     
Intraocular pressure increased *  1/375 (0.27%)  0/377 (0.00%) 
Musculoskeletal and connective tissue disorders     
Still’s disease adult onset *  0/375 (0.00%)  1/377 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign ovarian tumour *  0/375 (0.00%)  1/377 (0.27%) 
Nervous system disorders     
Multiple sclerosis *  1/375 (0.27%)  0/377 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed *  2/375 (0.53%)  3/377 (0.80%) 
Foetal distress syndrome *  0/375 (0.00%)  2/377 (0.53%) 
Premature separation of placenta *  2/375 (0.53%)  0/377 (0.00%) 
Abortion spontaneous complete *  1/375 (0.27%)  0/377 (0.00%) 
Abortion spontaneous incomplete *  0/375 (0.00%)  1/377 (0.27%) 
Ectopic pregnancy *  0/375 (0.00%)  1/377 (0.27%) 
Foetal growth restriction *  0/375 (0.00%)  1/377 (0.27%) 
Gestational hypertension *  1/375 (0.27%)  0/377 (0.00%) 
Intra-uterine death *  1/375 (0.27%)  0/377 (0.00%) 
Premature labour *  0/375 (0.00%)  1/377 (0.27%) 
Threatened labour *  1/375 (0.27%)  0/377 (0.00%) 
Psychiatric disorders     
Borderline personality disorder *  1/375 (0.27%)  0/377 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic granulomatous angiitis *  1/375 (0.27%)  0/377 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria *  1/375 (0.27%)  0/377 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00929526     History of Changes
Other Study ID Numbers: 112949
First Submitted: June 26, 2009
First Posted: June 29, 2009
Results First Submitted: February 16, 2012
Results First Posted: October 15, 2012
Last Update Posted: October 20, 2016