Dengue Fever
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to assess the humoral immune responses to three different dose schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in healthy participants between 2 and \<18 years of age living in dengue endemic countries.
Detailed description
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV) which was administered in 3 different dosing schedules to participants aged from 2 to 17 years resident in dengue endemic countries. This study looked at the titers of antibodies to dengue fever elicited in people who received TDV. The study randomized 1800 healthy participants. Participants were randomly assigned to one of the four treatment groups in a 1:2:5:1 ratio-which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need): * Group 1 - TDV 0.5 mL subcutaneous (SC) injection Days 1 and 91 * Group 2 - TDV 0.5 mL SC injection Day 1 * Group 3 - TDV 0.5 mL SC injection Days 1 and 365 * Group 4 - Placebo (dummy SC) - this is a liquid that looks like the study drug but has no active ingredient A total of 600 participants were planned to be randomly included in immunogenicity analyses (approximately 100 participants planned in each of Group 1 and Group 4, and 200 participants planned in each of Group 2 and Group 3). In order to keep the treatment arms undisclosed to the participant and the doctor, participants received a placebo injection at any study visit where TDV was not being administered (Days 1 and/or 91 and/or 365). Participants were asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 28 days after each vaccination. This multi-center trial was conducted in Asia and Latin America. Participants were followed for 48 months with 10 protocol-scheduled visits for participants included in the planned immunogenicity subset of approximately 600 subjects and 7 protocol-scheduled visits for subjects not included in the immunogenicity subset.
Interventions
TDV subcutaneous injection
BIOLOGICALTDV Placebo
Placebo-matching vaccine
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is aged 2 to \<18 years, at the time of enrolment. 2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. 3. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form (and assent form, where required) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. 4. Can comply with trial procedures and are available for the duration of follow-up.
Exclusion criteria
1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection at the time of enrolment. Trial entry should be delayed until the illness has improved. 2. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components; b. Female participants who are pregnant or breastfeeding; c. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome); d. Known or suspected impairment/alteration of immune function, including: i. Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed); ii. Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1; iii. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months preceding (first) vaccination; vi. Human immunodeficiency virus (HIV) infection or HIV-related disease; vii. Genetic immunodeficiency. 3. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration. 4. Individuals participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial. 5. Individuals who are first degree relatives of individuals involved in trial conduct. 6. If female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to trial entry: a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal (for at least 2 years), bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy; b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry. 7. If female of childbearing potential, sexually active and refuses to use an acceptable contraceptive method through to 6 weeks after the last dose of investigational vaccine. 8. Individuals who participated in a previous dengue vaccine trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | Up to Month 48 | GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | Months 1, 3, 6, 12, 13, 18, 24, 36, and 48 | Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | Within 7 days after each vaccination | Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as \[Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)\]. Erythema and Swelling at injection site were graded as Grade 0 (\<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: \> 20 - ≤ 40 mm) and 3 (severe: \> 40 mm). |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | Within 7 days after each vaccination | Solicited local injection site reactions were collected by participant diary and graded as \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\]. Erythema and Swelling at injection site were graded as Grade 0 (\<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: \> 50 - ≤ 100 mm). |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | Within 14 days after each vaccination | Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | Within 14 days after each vaccination | Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | Within 28 days after each vaccination | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With Serious Adverse Events (SAEs) | From first vaccination through end of study (Day 1460) | An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria. |
| Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination | From 30 days post-first vaccination through end of study (Day 1460) | Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group. |
Countries
Dominican Republic, Panama, Philippines
Participant flow
Recruitment details
Participants took part in the study at 3 investigative sites in Dominican Republic, Panama and Philippines from 05 Dec 2014 to 18 Feb 2019.
Pre-assignment details
Healthy volunteers were enrolled in a 1:2:5:1 ratio into 4 study groups: Group 1 received two doses of Tetravalent Dengue Vaccine (TDV), Group 2 received one dose of TDV, Group 3 received one dose of TDV along with booster vaccination and Group 4 received placebo.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (TDV 2-Dose) Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365. | 200 |
| Group 2 (TDV 1-Dose) Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365. | 398 |
| Group 3 (TDV 1-Dose + Booster) Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91. | 998 |
| Group 4 (Placebo Control) Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365. | 198 |
| Total | 1,794 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 4 | 5 | 24 | 7 |
| Overall Study | Pregnancy | 2 | 10 | 12 | 0 |
| Overall Study | Reason Not Specified | 1 | 1 | 9 | 1 |
| Overall Study | Withdrawal by Subject | 25 | 58 | 124 | 33 |
Baseline characteristics
| Characteristic | Group 1 (TDV 2-Dose) | Total | Group 4 (Placebo Control) | Group 3 (TDV 1-Dose + Booster) | Group 2 (TDV 1-Dose) |
|---|---|---|---|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 4.01 | 7.3 years STANDARD_DEVIATION 4.06 | 7.0 years STANDARD_DEVIATION 3.96 | 7.3 years STANDARD_DEVIATION 4.06 | 7.3 years STANDARD_DEVIATION 4.14 |
| Body Mass Index (BMI) | 17.42 kg/m^2 STANDARD_DEVIATION 3.558 | 17.30 kg/m^2 STANDARD_DEVIATION 3.2 | 16.93 kg/m^2 STANDARD_DEVIATION 2.975 | 17.29 kg/m^2 STANDARD_DEVIATION 3.123 | 17.43 kg/m^2 STANDARD_DEVIATION 3.306 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 165 Participants | 1465 Participants | 158 Participants | 825 Participants | 317 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 329 Participants | 40 Participants | 173 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 122.1 cm STANDARD_DEVIATION 22.59 | 121.2 cm STANDARD_DEVIATION 22.64 | 119.3 cm STANDARD_DEVIATION 21.88 | 121.4 cm STANDARD_DEVIATION 22.6 | 120.9 cm STANDARD_DEVIATION 23.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 102 Participants | 912 Participants | 101 Participants | 505 Participants | 204 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 331 Participants | 40 Participants | 174 Participants | 82 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 540 Participants | 56 Participants | 311 Participants | 110 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 11 Participants | 1 Participants | 8 Participants | 2 Participants |
| Sex: Female, Male Female | 100 Participants | 888 Participants | 95 Participants | 486 Participants | 207 Participants |
| Sex: Female, Male Male | 100 Participants | 906 Participants | 103 Participants | 512 Participants | 191 Participants |
| Weight | 27.86 kg STANDARD_DEVIATION 15.069 | 27.07 kg STANDARD_DEVIATION 13.924 | 25.66 kg STANDARD_DEVIATION 13.371 | 27.12 kg STANDARD_DEVIATION 13.612 | 27.25 kg STANDARD_DEVIATION 14.368 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 1 / 398 | 1 / 998 | 0 / 198 |
| other Total, other adverse events | 17 / 91 | 43 / 187 | 41 / 191 | 22 / 93 |
| serious Total, serious adverse events | 10 / 200 | 18 / 398 | 65 / 998 | 10 / 198 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.
Time frame: Up to Month 48
Population: Per Protocol Set (PPS): All participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 768.2 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 4329.7 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 422.3 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 1810.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 140.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 122.9 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 448.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 1461.5 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 150.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 109.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 370.7 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 1070.0 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 166.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 87.9 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 454.4 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 1152.4 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 192.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 90.5 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 475.9 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 1211.5 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 285.5 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 98.3 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 471.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 1395.5 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 243.0 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 180.0 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 495.2 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 1394.2 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 262.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 201.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 377.8 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 216.1 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 199.2 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 1051.9 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 183.4 titer |
| Group 1 (TDV 2-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 152.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 166.3 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 684.2 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 317.3 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 1241.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 85.6 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 4219.3 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 276.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 298.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 421.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 214.9 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 352.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 102.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 385.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 999.7 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 1529.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 441.5 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 170.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 1408.4 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 364.7 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 1748.2 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 110.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 1319.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 170.4 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 1384.1 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 1682.9 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 250.8 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 200.5 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 225.1 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 201.0 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 148.1 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 2216.9 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 86.3 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 409.6 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 164.1 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 463.7 titer |
| Group 2 (TDV 1-Dose) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 461.3 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 173.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 287.5 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 487.3 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 1041.0 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 199.2 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 251.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 89.3 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 538.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 1598.8 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 1335.1 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 1866.1 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 718.5 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 767.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 278.0 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 92.3 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 1056.3 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 1456.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 548.0 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 285.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 171.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 364.8 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 920.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 1685.8 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 470.1 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 218.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 742.8 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 1200.0 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 1476.2 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 920.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 3572.2 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 363.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 260.4 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 708.9 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 1709.6 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 236.1 titer |
| Group 3 (TDV 1-Dose + Booster) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 147.0 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 208.1 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 33.1 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 45.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 60.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 77.6 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 176.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 62.0 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 75.0 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 55.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 45.8 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 29.3 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 71.3 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 24.8 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 66.4 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 92.2 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 133.9 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 64.6 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 28.8 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 37.4 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 77.2 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 76.0 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 68.5 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 129.5 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 39.3 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 90.8 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 72.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 46.2 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 56.3 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 244.6 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 100.0 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 80.6 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 90.7 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 22.3 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 114.5 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 23.4 titer |
| Group 4 (Placebo Control) | Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 203.5 titer |
Secondary
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 28 days after each vaccination
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Safety Set included only participants from Immunogenicity Subset with data available for analyses. Number analyzed is number of participants with data available after each vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 1 | 19.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 3 | 6.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 2 | 12.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 2 | 10.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 1 | 20.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 3 | 12.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 2 | 11.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 1 | 19.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 3 | 10.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 1 | 21.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 3 | 9.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination | After Vaccination 2 | 16.1 percentage of participants |
Secondary
Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination
Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group.
Time frame: From 30 days post-first vaccination through end of study (Day 1460)
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination | 3.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination | 2.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination | 2.2 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination | 6.6 percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria.
Time frame: From first vaccination through end of study (Day 1460)
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Serious Adverse Events (SAEs) | 5.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Serious Adverse Events (SAEs) | 4.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Serious Adverse Events (SAEs) | 6.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Serious Adverse Events (SAEs) | 5.1 percentage of participants |
Secondary
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination
Solicited local injection site reactions were collected by participant diary and graded as \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\]. Erythema and Swelling at injection site were graded as Grade 0 (\<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: \> 50 - ≤ 100 mm).
Time frame: Within 7 days after each vaccination
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Moderate | 3.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Any | 31.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Mild | 20.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Moderate | 5.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Any | 16.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Severe | 6.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Mild | 23.3 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Moderate | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: (2.5-5 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Mild | 13.6 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Any | 25.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Any | 31.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema (2.5-5 cm) | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Any | 18.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Mild | 18.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Severe | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Any | 20.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Severe | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema: Any | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Severe | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: (2.5-5 cm) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Mild | 28.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Mild | 16.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema: Any | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Moderate | 2.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Moderate | 4.1 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Any | 10.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Any | 26.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Mild | 22.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema: Any | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: (2.5-5 cm) | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Mild | 6.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Moderate | 4.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Any | 19.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Mild | 15.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Moderate | 3.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema: Any | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema (2.5-5 cm) | 0.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Mild | 12.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: (2.5-5 cm) | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Swelling: Any | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Any | 8.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Moderate | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Moderate | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Pain: Mild | 7.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Moderate | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Mild | 10.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Erythema (2.5-5 cm) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Pain: Any | 16.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Pain: Any | 14.5 percentage of participants |
Secondary
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination
Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as \[Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)\]. Erythema and Swelling at injection site were graded as Grade 0 (\<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: \> 20 - ≤ 40 mm) and 3 (severe: \> 40 mm).
Time frame: Within 7 days after each vaccination
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Any | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Mild | 11.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Mild | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling (1-2 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Mild | 7.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Any | 7.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Any | 11.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema (1-2 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling (1-2 cm) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling (1-2 cm) | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Moderate | 3.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Mild | 7.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema: Any | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Mild | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling (1-2 cm) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Moderate | 1.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Mild | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Any | 8.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema (1-2 cm) | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling: Any | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Any | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling: Any | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Any | 5.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Severe | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Mild | 10.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Moderate | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema (1-2 cm) | 3.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Any | 12.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema: Any | 3.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling (1-2 cm) | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Any | 13.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Mild | 9.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Moderate | 3.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Any | 15.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Mild | 11.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling: Any | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling (1-2 cm) | 1.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Moderate | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Mild | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling (1-2 cm) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Swelling: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Mild | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema (1-2 cm) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Erythema: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Pain: Any | 7.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling (1-2 cm) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Swelling: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Pain: Any | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Mild | 6.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Pain: Any | 6.9 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination
Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Time frame: Within 14 days after each vaccination
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Any | 10.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: Any | 2.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Mild | 10.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Mild | 8.3 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Moderate | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Any | 20.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 39.5 - < 40.0 °C | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Moderate | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.0 - < 38.5 °C | 2.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Severe | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Mild | 10.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Severe | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: Any | 5.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Any | 15.3 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.0 - < 38.5 °C | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.5 - < 39.0 °C | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.0 - < 38.5 °C | 2.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 39.0 - < 39.5 °C | 1.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Mild | 16.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Mild | 3.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.5 - < 39.0 °C | 2.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Mild | 10.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.0 - < 39.5 °C | 2.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Moderate | 3.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Any | 5.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.5 - < 40.0 °C | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Moderate | 3.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Any | 8.3 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Any | 18.6 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Mild | 11.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Mild | 5.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Moderate | 3.3 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Mild | 6.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Any | 10.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Severe | 3.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Moderate | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Moderate | 5.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Any | 16.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Any | 8.5 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: Any | 1.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Mild | 6.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Mild | 5.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Any | 5.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Any | 6.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Moderate | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Severe | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.5 - < 39.0 °C | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Any | 6.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Severe | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Severe | 1.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Mild | 3.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: Any | 2.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Any | 8.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Severe | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Mild | 6.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Moderate | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Moderate | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Any | 11.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Severe | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Any | 7.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Mild | 7.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Any | 5.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Mild | 5.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Mild | 10.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Any | 11.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Severe | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Moderate | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 39.5 - < 40.0 °C | 1.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: Any | 2.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.0 - < 38.5 °C | 1.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Moderate | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.5 - < 39.0 °C | 1.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.5 - < 39.0 °C | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Mild | 9.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Any | 14.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Mild | 13.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Any | 11.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Moderate | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 39.0 - < 39.5 °C | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Any | 20.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.0 - < 38.5 °C | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Mild | 18.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Severe | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Any | 23.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Moderate | 2.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Moderate | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Mild | 5.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.0 - < 38.5 °C | 1.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.5 - < 39.0 °C | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Mild | 20.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Any | 7.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.0 - < 39.5 °C | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.5 - < 40.0 °C | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Severe | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Any | 9.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: Any | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Mild | 7.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Moderate | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Moderate | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Moderate | 2.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Severe | 0.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Mild | 5.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Mild | 7.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Any | 7.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Severe | 0.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Severe | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Mild | 7.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.5 - < 40.0 °C | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Mild | 5.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Any | 16.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Mild | 13.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Moderate | 1.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Severe | 1.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Any | 7.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Mild | 4.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Moderate | 1.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Any | 8.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Moderate | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Any | 11.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Mild | 10.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Moderate | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: Any | 4.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.0 - < 38.5 °C | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.5 - < 39.0 °C | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.0 - < 39.5 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Any | 6.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Mild | 4.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Moderate | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Any | 4.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Mild | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Any | 6.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Mild | 4.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Any | 5.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Mild | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Moderate | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: Any | 2.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.0 - < 38.5 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.5 - < 39.0 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 39.5 - < 40.0 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Any | 7.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Mild | 5.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Any | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Mild | 2.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Moderate | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Any | 8.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Mild | 5.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Any | 8.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Severe | 0.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: Any | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.0 - < 38.5 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.5 - < 39.0 °C | 0.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 39.0 - < 39.5 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Moderate | 5.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Mild | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Mild | 14.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Any | 7.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Asthenia: Any | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Mild | 7.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Moderate | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Mild | 12.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: Any | 2.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Headache: Any | 16.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.5 - < 40.0 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Any | 21.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Asthenia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 39.0 - < 39.5 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.5 - < 39.0 °C | 3.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.0 - < 38.5 °C | 2.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: 38.0 - < 38.5 °C | 2.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Fever: Any | 5.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Any | 7.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Mild | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Moderate | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Myalgia: Mild | 7.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Mild | 8.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Malaise: Any | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Any | 5.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Malaise: Any | 10.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Mild | 5.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Moderate | 3.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Mild | 3.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.0 - < 38.5 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 39.0 - < 39.5 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 38.5 - < 39.0 °C | 2.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: Any | 4.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Myalgia: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Fever: 39.5 - < 40.0 °C | 2.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Mild | 5.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Asthenia: Any | 7.0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Any | 7.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Myalgia: Any | 5.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 1, Headache: Severe | 1.8 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Mild | 5.5 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Mild | 7.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Fever: 38.5 - < 39.0 °C | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 3, Headache: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination | After Vaccination 2, Malaise: Any | 9.1 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination
Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Time frame: Within 14 days after each vaccination
Population: Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Mild | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.5 - < 39.0 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (39.0 - < 39.5 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Any | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Mild | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite:Any | 7.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite: Mild | 7.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever: Any | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.5 - < 39.0 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability:Any | 15.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability: Mild | 15.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness: Any | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness:Mild | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Any | 7.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Mild | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Moderate | 3.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever, Any | 16.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.5 - < 39.0 °C) | 8.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.0 - < 39.5 °C) | 4.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.5 - < 40.0 °C) | 4.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Irritability: Any | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Mild | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Any | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Mild | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Moderate | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Severe | 0 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Loss of Appetite: Any | 7.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Mild | 3.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Moderate | 3.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Mild | 7.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite:Any | 9.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Loss of Appetite: Any | 12.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite: Mild | 7.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Moderate | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever: Any | 6.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.0 - < 38.5 °C) | 2.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Any | 3.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.5 - < 39.0 °C) | 4.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability:Any | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability: Mild | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness: Any | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Mild | 3.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness:Mild | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Any | 13.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Moderate | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Moderate | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Severe | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever, Any | 9.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.0 - < 38.5 °C) | 3.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Mild | 7.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.5 - < 39.0 °C) | 5.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.0 - < 39.5 °C) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Moderate | 5.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.5 - < 40.0 °C) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever: Any | 3.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.5 - < 39.0 °C) | 1.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (39.0 - < 39.5 °C) | 1.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Irritability: Any | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Any | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Mild | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Moderate | 1.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Severe | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Mild | 0 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Any | 7.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Mild | 9.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability: Mild | 1.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.5 - < 39.0 °C) | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness: Any | 3.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness:Mild | 3.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Mild | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Mild | 3.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Any | 5.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Mild | 5.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (39.0 - < 39.5 °C) | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Moderate | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Severe | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever, Any | 11.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Any | 9.1 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.0 - < 38.5 °C) | 5.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Irritability: Any | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.5 - < 39.0 °C) | 3.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Mild | 3.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.0 - < 39.5 °C) | 1.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Severe | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Mild | 5.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Mild | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Moderate | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Moderate | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite:Any | 10.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite: Mild | 5.5 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Any | 7.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever: Any | 3.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Moderate | 3.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Moderate | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Severe | 1.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.5 - < 40.0 °C) | 0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever: Any | 5.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Loss of Appetite: Any | 3.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Moderate | 3.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.0 - < 38.5 °C) | 3.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.0 - < 38.5 °C) | 1.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.5 - < 39.0 °C) | 1.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Any | 3.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability:Any | 1.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever: Any | 6.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability: Mild | 10.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Loss of Appetite: Any | 10.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Mild | 7.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.5 - < 39.0 °C) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Severe | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Drowsiness:Mild | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Mild | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Moderate | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Drowsiness: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Mild | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Irritability: Mild | 6.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Mild | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Mild | 6.9 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (38.0 - < 38.5 °C) | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Irritability:Any | 10.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Fever (39.0 - < 39.5 °C) | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Any | 7.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite:Any | 7.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Loss of Appetite: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3, Loss of Appetite: Moderate | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Irritability: Any | 10.3 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever: Any | 3.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever, Any | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Drowsiness: Moderate | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1,Loss of Appetite: Mild | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.5 - < 39.0 °C) | 3.7 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Any | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 3,Drowsiness: Any | 3.4 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.5 - < 40.0 °C) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (38.5 - < 39.0 °C) | 3.6 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Irritability: Severe | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Loss of Appetite: Moderate | 7.1 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 1, Fever (38.0 - < 38.5 °C) | 0 percentage of participants |
| Group 4 (Placebo Control) | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination | After Vaccination 2, Fever (39.0 - < 39.5 °C) | 0 percentage of participants |
Secondary
Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset
Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Months 1, 3, 6, 12, 13, 18, 24, 36, and 48
Population: PPS included all participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 95.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 96.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 98.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 89.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 94.9 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 98.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 98.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 92.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 94.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 95.1 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 88.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 96.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 98.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 95.2 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 97.6 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 87.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 90.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 97.5 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 98.7 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 92.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 94.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 98.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 95.5 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 97.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 94.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 95.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 95.4 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 90.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 98.8 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 100.0 percentage of participants |
| Group 1 (TDV 2-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 88.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 92.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 95.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 86.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 92.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 97.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 99.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 92.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 86.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 93.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 88.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 88.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 91.0 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 94.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 98.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 90.2 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 97.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 97.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 95.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 90.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 93.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 97.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 95.9 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 98.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 95.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 90.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 97.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 99.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 99.3 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 90.6 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 97.5 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 99.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 98.8 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 94.4 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 85.1 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 91.7 percentage of participants |
| Group 2 (TDV 1-Dose) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 95.7 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 98.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 99.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 90.2 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 99.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 98.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 99.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 93.1 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 85.1 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 98.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 82.9 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 97.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 96.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 97.1 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 90.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 97.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 98.3 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 95.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 98.6 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 99.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 90.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 99.4 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 98.8 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 100.0 percentage of participants |
| Group 3 (TDV 1-Dose + Booster) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 91.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 365 (Month 12) | 57.9 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 28 (Month 1) | 49.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 91 (Month 3) | 45.7 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 180 (Month 6) | 48.1 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 540 (Month 18) | 57.5 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 730 (Month 24) | 68.6 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 730 (Month 24) | 71.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 730 (Month 24) | 61.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1095 (Month 36) | 71.2 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1095 (Month 36) | 63.6 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1460 (Month 48) | 68.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 1460 (Month 48) | 68.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1460 (Month 48) | 63.5 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 28 (Month 1) | 49.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 28 (Month 1) | 51.9 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 28 (Month 1) | 50.6 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 91 (Month 3) | 51.9 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 91 (Month 3) | 53.1 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 91 (Month 3) | 48.1 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 180 (Month 6) | 49.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 180 (Month 6) | 49.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 180 (Month 6) | 44.4 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 365 (Month 12) | 60.5 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 365 (Month 12) | 57.9 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 365 (Month 12) | 55.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 393 (Month 13) | 60.0 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 393 (Month 13) | 61.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 393 (Month 13) | 57.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 393 (Month 13) | 53.3 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 540 (Month 18) | 62.5 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-2, Day 540 (Month 18) | 68.8 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 540 (Month 18) | 63.8 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 730 (Month 24) | 65.7 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-1, Day 1095 (Month 36) | 68.2 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-3, Day 1095 (Month 36) | 63.6 percentage of participants |
| Group 4 (Placebo Control) | Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset | DENV-4, Day 1460 (Month 48) | 60.3 percentage of participants |