Trial Outcomes & Findings for Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women (NCT NCT00344032)
NCT ID: NCT00344032
Last Updated: 2018-07-20
Results Overview
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
354 participants
Primary outcome timeframe
At Month 7
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Cervarix
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
178
|
|
Overall Study
COMPLETED
|
162
|
168
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Cervarix
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Physician Decision
|
4
|
1
|
Baseline Characteristics
Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women
Baseline characteristics by cohort
| Measure |
Cervarix
n=176 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 Years
STANDARD_DEVIATION 4.70 • n=5 Participants
|
28.5 Years
STANDARD_DEVIATION 4.97 • n=7 Participants
|
28.5 Years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Outcome measures
| Measure |
Cervarix
n=124 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=139 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16
|
124 Participants
|
16 Participants
|
|
Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18
|
117 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Months 0 and 7Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix
n=148 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=158 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 0)
|
5.4 EL.U/mL
Interval 4.7 to 6.1
|
4.9 EL.U/mL
Interval 4.4 to 5.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 7)
|
9813.8 EL.U/mL
Interval 8605.4 to 11191.9
|
6.0 EL.U/mL
Interval 5.1 to 7.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 0)
|
4.7 EL.U/mL
Interval 4.2 to 5.2
|
4.6 EL.U/mL
Interval 4.2 to 5.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 7)
|
4030.1 EL.U/mL
Interval 3544.0 to 4582.8
|
4.9 EL.U/mL
Interval 4.3 to 5.5
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0 - 6) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.
Outcome measures
| Measure |
Cervarix
n=171 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=174 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms
Headache
|
72 Participants
|
71 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Pain
|
137 Participants
|
105 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Redness
|
56 Participants
|
24 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Swelling
|
69 Participants
|
35 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Arthralgia
|
19 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Fatigue
|
84 Participants
|
83 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Fever (above 37.5 degree Celsius)
|
51 Participants
|
48 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Gastro-intestinal symptoms
|
25 Participants
|
28 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Myalgia
|
10 Participants
|
11 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Rash
|
5 Participants
|
8 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Urticaria
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 30 days (Days 0 - 29) after each vaccinationUnsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Outcome measures
| Measure |
Cervarix
n=176 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 7)NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
Outcome measures
| Measure |
Cervarix
n=176 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)
NOCDs
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)
Medically Significant AEs
|
13 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 7)Serious adverse events assessed include medical occurrences that results in death, is 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.
Outcome measures
| Measure |
Cervarix
n=176 Participants
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 Participants
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events
|
2 Participants
|
4 Participants
|
Adverse Events
Cervarix
Serious events: 2 serious events
Other events: 153 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix
n=176 participants at risk
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 participants at risk
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Aborption spontaneous
|
0.00%
0/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.56%
1/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Infections and infestations
Appendicitis
|
0.57%
1/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.00%
0/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.56%
1/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Eye disorders
Cataract
|
0.00%
0/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.56%
1/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Infections and infestations
Lymph node tuberculosis
|
0.57%
1/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.00%
0/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.56%
1/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
Other adverse events
| Measure |
Cervarix
n=176 participants at risk
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
|
Placebo
n=178 participants at risk
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
|
|---|---|---|
|
General disorders
Pain
|
77.8%
137/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
59.0%
105/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Redness
|
31.8%
56/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
13.5%
24/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Swelling
|
39.2%
69/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
19.7%
35/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Arthralgia
|
10.8%
19/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
9.0%
16/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Fatigue
|
47.7%
84/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
46.6%
83/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Fever (above 37.5 degree Celsius)
|
29.0%
51/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
27.0%
48/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Gastro-intestinal symptoms
|
14.2%
25/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
15.7%
28/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Headache
|
40.9%
72/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
39.9%
71/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Myalgia
|
5.7%
10/176
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
6.2%
11/178
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER