Dengue, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue, Dengue Hemorrhagic Fever, CYD Dengue Vaccines, Pentaxim™
Brief summary
The aim of the study was to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day visit but in 2 different sites of administration. Primary Objective: * To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo. Secondary Objectives: * To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo. * To describe the safety of the CYD dengue vaccine after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06). * To describe the safety of the CYD dengue vaccine in all participants after each dose. * To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine (at Visit 05) or administered alone (at Visit 06). * To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.
Detailed description
Participants required 8 or 9 clinic visits and received a total of 7 injections. The dengue post-vaccinal viremia was assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity was assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. Participants were followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.
Interventions
BIOLOGICALLive, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
BIOLOGICALDTaP IPV//Hib vaccine
0.5 mL, intramuscular
BIOLOGICALPlacebo
0.5 mL, subcutaneous
BIOLOGICALMeasles, mumps, and rubella vaccine
0.5 mL, subcutaneous
BIOLOGICALPneumococcal vaccine
0.5 mL, intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An observer-blind design was chosen since the products were visually different. For the second dose of CYD dengue vaccine, the person who administered the injections knew which product was administered while the subject/parent and Investigator were blinded. The first and third doses of CYD dengue vaccine were administered according to an open-label procedure. A placebo dose was administered at Month 7(Group 1) and concomitantly with Pentaxim vaccine at Month 6 (Group 2) to maintain the blind.
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 9 to 12 months on the day of inclusion. * Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg. * Participant in good health, based on medical history and physical examination. * Documentation of completion of the primary vaccination series with Pentaxim vaccine with the 3 doses received between 2 and 8 months of age. * Informed consent form had been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations). * Participant and parent/guardian attended all scheduled visits and comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Hib and/or polio. * Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as reported by the parent(s)/legally acceptable representative. * History of pertussis and/or Hib infection as reported by the parent(s)/legally acceptable representative. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * History of contraindication to the receipt of vaccines containing components of Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin, polyribosylribitol phosphate \[PRP\] and polio) or of measles, mumps and rubella vaccine and of pneumococcal vaccine. * Thrombocytopenia, as reported by the parent(s)/legally acceptable representative. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * History of central nervous system disorder or disease, including seizures. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | 28 days post-injection | Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as \>=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, \>=8 1/dil for poliovirus types 1, 2, and 3, and \>=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were \< lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels \>=4\* LLOQ; participants whose pre-vaccination Ab concentrations were \>=LLOQ but \<4\* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels \>=4); for participants whose pre-vaccination Ab concentrations were \>=4\* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination \>=2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Pre-injection 1 and 28 days post-injection 2 and 3 | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT. |
| Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Pre-injection 1 and 28 days post-injection 2 and 3 | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution). |
| Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | Pre-injection 1 and 28 days post-injection 2 and 3 | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution). |
| Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Pre-injection 1 and 28 days post-injection 2 and 3 | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT). |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Day 0 up to Day 14 post-booster injection | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable; and Extensive swelling, severe. |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Day 0 up to Day 14 post-second injection | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Day 0 up to Day 14 post-third injection | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Day 0 up to Day 14 post-first injection | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 3 Solicited injection site reactions: Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5 degree Celsius (°C); Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. |
Countries
Mexico
Participant flow
Recruitment details
Study participants were enrolled from 18 July 2011 to 31 July 2012 at 3 clinical sites in Mexico. The study planned for 732 participants; however, recruitment was stopped when 720 participants were enrolled due to the difficulty in enrolling participants.
Pre-assignment details
A total of 720 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled, out of which 309 participants were randomized to Group 1 and 315 in Group 2, and 96 participants were not randomized to Group 1 or 2.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group 1 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). | 309 |
| CYD Dengue Vaccine Group 2 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). | 315 |
| Total | 624 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Protocol Violation | 0 | 5 |
| Overall Study | Serious Adverse Event | 0 | 3 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group 1 | CYD Dengue Vaccine Group 2 | Total |
|---|---|---|---|
| Age, Customized 1 month to 23 months | 309 Participants | 315 Participants | 624 Participants |
| Sex: Female, Male Female | 146 Participants | 139 Participants | 285 Participants |
| Sex: Female, Male Male | 163 Participants | 176 Participants | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 309 | 1 / 315 |
| other Total, other adverse events | 145 / 309 | 142 / 315 |
| serious Total, serious adverse events | 17 / 309 | 21 / 315 |
Outcome results
Primary
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as \>=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, \>=8 1/dil for poliovirus types 1, 2, and 3, and \>=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were \< lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels \>=4\* LLOQ; participants whose pre-vaccination Ab concentrations were \>=LLOQ but \<4\* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels \>=4); for participants whose pre-vaccination Ab concentrations were \>=4\* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination \>=2).
Time frame: 28 days post-injection
Population: Per-protocol analysis set:all participants who had no protocol deviations (not meet inclusion/exclusion criteria,not received vaccine in time window, administration not done per protocol) and could impact Pentaxim vaccine immunogenicity up to Visit 06 (Month 07). Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-diphtheria | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-tetanus | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 1 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-PRP | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-PT | 96.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-FHA | 93.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 3 | 100 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 3 | 99.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-diphtheria | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-PRP | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-tetanus | 99.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-FHA | 93.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 1 | 99.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-PT | 97.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Anti-polio 2 | 100.0 Percentage of participants |
Comparison: Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.48, 1.4]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.14, 2.07]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.14, 2.08]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.48, 1.4]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.15, 2.09]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-1.48, 1.4]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-3.93, 2.69]
Comparison: Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.95% CI: [-4.87, 4.06]
Secondary
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT.
Time frame: Pre-injection 1 and 28 days post-injection 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1: Post-inj 2 value/pre-inj 1 value | 3.81 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1: Post-inj 3 value/pre-inj 1 value | 8.91 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2: Post-inj 2 value/pre-inj 1 value | 10.6 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2: Post-inj 3 value/pre-inj 1 value | 18.3 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3: Post-inj 2 value/pre-inj 1 value | 8.97 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3: Post-inj 3 value/pre-inj 1 value | 19.1 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4: Post-inj 2 value/pre-inj 1 value | 5.73 Titer ratio |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4: Post-inj 3 value/pre-inj 1 value | 12.0 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4: Post-inj 3 value/pre-inj 1 value | 12.6 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1: Post-inj 2 value/pre-inj 1 value | 5.97 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3: Post-inj 2 value/pre-inj 1 value | 11.1 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1: Post-inj 3 value/pre-inj 1 value | 9.20 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4: Post-inj 2 value/pre-inj 1 value | 10.0 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2: Post-inj 2 value/pre-inj 1 value | 11.5 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3: Post-inj 3 value/pre-inj 1 value | 20.6 Titer ratio |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2: Post-inj 3 value/pre-inj 1 value | 19.6 Titer ratio |
Secondary
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post-injection 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity which included participants randomized into the dengue immunogenicity subset who received at least one dose of CYD dengue vaccine. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Pre-injection 1 | 5.28 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 2 | 39.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 3 | 93.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Pre-injection 1 | 5.22 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 2 | 109 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 3 | 189 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Pre-injection 1 | 5.26 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 2 | 92.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 3 | 196 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Pre-injection 1 | 5.11 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 2 | 57.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group 1 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 3 | 121 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 2 | 104 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Pre-injection 1 | 5.35 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Pre-injection 1 | 5.38 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 2 | 62.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Pre-injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 3 | 97.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 2 | 116 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Pre-injection 1 | 5.53 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 3 | 127 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 2 | 121 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 3 | 217 Titers (1/dilution) |
| CYD Dengue Vaccine Group 2 | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 3 | 208 Titers (1/dilution) |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable; and Extensive swelling, severe.
Time frame: Day 0 up to Day 14 post-booster injection
Population: Analysis was performed on Safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Pentaxim | 13.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness; Post- Pentaxim | 37.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness; Post- Pentaxim | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness; Post-CYD dengue/placebo | 33.2 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Tenderness;Post-CYD dengue/placebo | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema | 15.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness | 43.2 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema; Post- Pentaxim | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-CYD dengue/placebo | 8.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Erythema; Post-CYD dengue/placebo | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling | 11.6 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Pentaxim | 9.4 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling; Post- Pentaxim | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-CYD dengue/placebo | 5.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Swelling; Post-CYD dengue/placebo | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site extensive swelling; Post- Pentaxim | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site extensive swelling; Post- Pentaxim | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Fever | 29.1 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Fever | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Vomiting | 11.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Vomiting | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Crying abnormal | 33.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Crying abnormal | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Drowsiness | 19.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Drowsiness | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Appetite lost | 23.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Appetite lost | 3.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Irritability | 37.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Irritability | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Irritability | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness | 42.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-CYD dengue/placebo | 7.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Crying abnormal | 30.8 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness; Post- Pentaxim | 37.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Swelling; Post-CYD dengue/placebo | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness; Post- Pentaxim | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Appetite lost | 23.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness; Post-CYD dengue/placebo | 30.5 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site extensive swelling; Post- Pentaxim | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Tenderness;Post-CYD dengue/placebo | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Crying abnormal | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema | 20.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site extensive swelling; Post- Pentaxim | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Irritability | 39.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Pentaxim | 17.8 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Fever | 24.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema; Post- Pentaxim | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Drowsiness | 17.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-CYD dengue/placebo | 13.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grd 3 Inj. site Erythema; Post-CYD dengue/placebo | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Appetite lost | 3.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling | 17.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Vomiting | 11.8 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Drowsiness | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Pentaxim | 16.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Vomiting | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling; Post- Pentaxim | 0.0 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.
Time frame: Day 0 up to Day 14 post-second injection
Population: Analysis was performed on Safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness | 24.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema | 8.2 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Fever | 16.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Vomiting | 6.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Vomiting | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Crying abnormal | 21.2 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Crying abnormal | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Drowsiness | 11.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Drowsiness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Appetite lost | 17.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Appetite lost | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Irritability | 23.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Irritability | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Drowsiness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Tenderness | 25.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Vomiting | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Tenderness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Irritability | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema | 10.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Crying abnormal | 24.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Appetite lost | 20.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling | 5.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Crying abnormal | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Injection site Swelling | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Irritability | 25.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Fever | 18.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Drowsiness | 14.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Fever | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Grade 3 Appetite lost | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | Vomiting | 8.8 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.
Time frame: Day 0 up to Day 14 post-third injection
Population: Analysis was performed on Safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Vomiting | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Tenderness | 19.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Tenderness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Erythema | 6.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Swelling | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Swelling | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Fever | 16.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Fever | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Vomiting | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Crying abnormal | 21.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Crying abnormal | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Drowsiness | 10.4 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Drowsiness | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Appetite lost | 18.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Appetite lost | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Irritability | 23.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Irritability | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Drowsiness | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Vomiting | 7.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Vomiting | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Tenderness | 25.4 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Irritability | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Tenderness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Crying abnormal | 18.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Erythema | 5.8 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Appetite lost | 18.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Crying abnormal | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Injection site Swelling | 2.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Irritability | 20.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Injection site Swelling | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Drowsiness | 10.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Fever | 15.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Appetite lost | 2.4 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 3 Solicited injection site reactions: Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5 degree Celsius (°C); Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.
Time frame: Day 0 up to Day 14 post-first injection
Population: Analysis was performed on Safety analysis set which included participants who received at least one dose of CYD dengue vaccine, Pentaxim vaccine or placebo. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Vomiting | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Tenderness | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Crying abnormal | 36.4 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Swelling | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Crying abnormal | 2.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Tenderness | 29.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Drowsiness | 24.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Fever | 25.1 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Drowsiness | 1.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Erythema | 14.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Appetite lost | 32.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Fever | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Appetite lost | 4.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Swelling | 4.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Irritability | 47.1 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Vomiting | 18.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Irritability | 3.2 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Irritability | 4.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Tenderness | 33.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Tenderness | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Erythema | 15.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Swelling | 10.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Swelling | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Fever | 28.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Vomiting | 17.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Vomiting | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Crying abnormal | 38.5 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Crying abnormal | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Drowsiness | 23.4 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Drowsiness | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Appetite lost | 34.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Appetite lost | 4.5 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Injection site Irritability | 45.5 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Grade 3 Injection site Erythema | 0.0 Percentage of participants |
Secondary
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution).
Time frame: Pre-injection 1 and 28 days post-injection 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Pre-injection 1 | 1.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 2 | 84.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Pre-injection 1 | 1.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 2 | 98.1 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Pre-injection 1 | 2.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Pre-injection 1 | 1.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 2 | 90.5 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 2 | 96.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Pre-injection 1 | 2.8 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Pre-injection 1 | 3.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 2 | 92.2 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Pre-injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 1; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 2 | 98.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Pre-injection 1 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 4; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 2 | 96.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 3; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Serotype 2; Post-injection 3 | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine
Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution).
Time frame: Pre-injection 1 and 28 days post-injection 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Pre-injection 1 | 4.6 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Post-injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Pre-injection 1 | 1.8 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Post-injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Pre-injection 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Post-injection 2 | 94.3 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Pre-injection 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Post-injection 2 | 79.0 Percentage of participants |
| CYD Dengue Vaccine Group 1 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Post-injection 2 | 89.3 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Pre-injection 1 | 8.4 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Pre-injection 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Post-injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Pre-injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 1 serotype; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Post-injection 2 | 95.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Pre-injection 1 | 1.9 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | All 4 serotypes; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Post-injection 2 | 98.1 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 3 serotypes; Post-injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group 2 | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine | At least 2 serotypes; Post-injection 3 | 100.0 Percentage of participants |