Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants |
GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (>=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain. |
28 days after the last Cervarix vaccination |
|
Primary |
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants |
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
28 days after third CYD dengue vaccination |
|
Secondary |
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants |
The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
Day 0 and 28 days after each Cervarix vaccination |
|
Secondary |
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants |
Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [>] lower limit of quantitation [LLOQ] of the assay) or >=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens > LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (<) 2.0 International Units per milliliter (IU/mL). |
28 days after each Cervarix vaccination |
|
Secondary |
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants |
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
Day 0 and 28 days after each CYD dengue vaccine vaccination |
|
Secondary |
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants |
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
Day 0 and 28 days after each CYD dengue vaccine vaccination |
|
Secondary |
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants |
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
Day 0 and 28 days after each CYD dengue vaccination |
|
Secondary |
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants |
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (<10, >=10 and >=100 [1/dil]) against each dengue virus serotypes of CYD were reported. |
Day 0 and 28 days after each CYD dengue vaccination |
|
Secondary |
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine |
Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE. |
Within 30 minutes after each and any vaccination |
|
Secondary |
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine |
Solicited injection site reactions included pain, erythema, and swelling. |
Up to 7 days after each and any vaccination |
|
Secondary |
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine |
Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination. |
Up to 14 days after any and each vaccination |
|
Secondary |
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine |
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination. |
Up to 28 days after any and each vaccination |
|
Secondary |
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine |
AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
Up to 7 days after any and each vaccination |
|
Secondary |
Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine |
An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
From Day 0 up to 6 months after the last CYD or Cervarix vaccination |
|
Secondary |
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine |
Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions. |
From Day 0 up to 6 months after the last CYD or Cervarix vaccination |
|