| Primary | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At one month after vaccination with Nimenrix (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenA | | | Title | Measurements |
|---|
| - OG0005517.1(4791.4 to 6352.6)
- OG0015523.5(4913.2 to 6209.6)
- OG0024649.6(4022.8 to 5374.0)
|
| | rSBA-MenC |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers. | ANCOVA | | | | Adjusted GMT Ratio | 1.19 | | | 2-Sided | 95 | 0.99 | 1.43 | | | | | Non-Inferiority | The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2. | | |
|
| Primary | Anti-HPV-16 and Anti-HPV-18 Concentrations | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). | The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At one month after vaccination with Cervarix (Month 7) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Cervarix Group | Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Primary | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Count of Participants | | Participants | | At one month after Boostrix vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Boostrix+Cervarix Group | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Primary | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At one month after Boostrix vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Boostrix+Cervarix Group | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix. | Posted | | Count of Participants | | Participants | | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Nimenrix+Cervarix+Boostrix Group |
|
| Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:
- For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.
- For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination.
| The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix. | Posted | | Count of Participants | | Participants | | At one month after Nimenrix vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group. | The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group. | Posted | | Count of Participants | | Participants | | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Anti-T Antibody Concentrations | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group. | The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL). | The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination. | Posted | | Count of Participants | | Participants | | Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group] | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 |
|
| Secondary | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL. | The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination. | Posted | | Count of Participants | | Participants | | Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | |
|
| Secondary | Anti-HPV-16 and Anti-HPV-18 Concentrations | The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | Prior to and one month after the third dose of Cervarix (Months 0 and 8) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Booster responses to the PT, FHA and PRN antigens were defined as:
- For initially seronegative subjects (antibody concentrations: < 2.046 IU/ml for anti-FHA, < 2.187 IU/ml for anti-PRN, < 2.693 IU/ml for anti-PT), antibody concentration ≥ 4*cut_off IU/ml at Month 1 post-vaccination;
- For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration < 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration;
- For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration.
| The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Count of Participants | | Participants | | At one month after Boostrix vaccination (Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Boostrix+Cervarix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Count of Participants | | Participants | | Prior to and one month after Boostrix vaccination (Month 0 and Month 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Boostrix+Cervarix Group | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Anti-D and Anti-T Antibody Concentrations | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to and one month after Boostrix vaccination (Months 0 and 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Boostrix+Cervarix Group | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix. | Posted | | Count of Participants | | Participants | | Prior to and one month after Boostrix vaccination (Months 0 and 1) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix+Boostrix Group | Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Boostrix+Cervarix Group | Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
| |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With Unsolicited Adverse Events AE(s) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With Serious Adverse Events SAE(s) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the entire study period (from Month 0 to Month 8) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Cervarix Group | Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the entire study period (from Month 0 to Month 8) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Cervarix Group | Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. |
|
| Secondary | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the entire study period (from Month 0 to Month 8) | | | | ID | Title | Description |
|---|
| OG000 | Nimenrix+Cervarix (1,2,7-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG001 | Nimenrix+Cervarix (0,1,6-Month) Group | Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | | OG002 | Cervarix Group | Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. | |
|