Whole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus Influenzae Type b, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
Conditions
Keywords
Hib & Neisseria meningitidis serogroups A & C diseases
Brief summary
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
Detailed description
Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.
Interventions
BIOLOGICALTritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
BIOLOGICALTritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
BIOLOGICALMencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
427 Days to 577 Days
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. * Chronic administration (\> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly. * Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Fever >39°C (Rectal Route). | During the 4-day (Day 0-3) follow-up period after booster vaccination | Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | During the 4-day (Day 0-3) follow-up period after vaccination | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 4-day (Day 0-3) follow-up period after booster vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | During the 31-day (Day 0-30) following booster vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs). | From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Countries
Philippines, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACAC_Thailand Group Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age | 193 |
| ACHibPS_Thailand Group Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm | 96 |
| HibACPS_Thailand Group Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm | 65 |
| HibHibPS_Thailand Group Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 33 |
| ACAC_Philippines Group Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age | 205 |
| ACHibPS_Philippines Group Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 104 |
| HibACPS_Philippines Group Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 69 |
| HibHibPS_Philippines Group Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 33 |
| Total | 798 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Migrated/moved from study area | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 17.7 Months STANDARD_DEVIATION 0.7 | 17.8 Months STANDARD_DEVIATION 0.71 | 17.7 Months STANDARD_DEVIATION 0.78 | 17.6 Months STANDARD_DEVIATION 0.7 | 17.1 Months STANDARD_DEVIATION 0.78 | 17.2 Months STANDARD_DEVIATION 0.79 | 17.2 Months STANDARD_DEVIATION 0.93 | 17 Months STANDARD_DEVIATION 0.77 | 17.59 Months STANDARD_DEVIATION 0.76 |
| Sex: Female, Male Female | 96 Participants | 45 Participants | 32 Participants | 18 Participants | 107 Participants | 56 Participants | 29 Participants | 16 Participants | 399 Participants |
| Sex: Female, Male Male | 97 Participants | 51 Participants | 33 Participants | 15 Participants | 98 Participants | 48 Participants | 40 Participants | 17 Participants | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 398 | 0 / 200 | 0 / 134 | 0 / 66 |
| other Total, other adverse events | 376 / 398 | 181 / 200 | 129 / 134 | 60 / 66 |
| serious Total, serious adverse events | 5 / 398 | 1 / 200 | 0 / 134 | 0 / 66 |
Outcome results
Primary
Number of Subjects With Fever >39°C (Rectal Route).
Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C.
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Population: This analysis was performed on Booster Total Vaccinated cohort which included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACAC_Thailand Group | Number of Subjects With Fever >39°C (Rectal Route). | 22 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Fever >39°C (Rectal Route). | 8 Participants |
| HibACPS_Thailand Group | Number of Subjects With Fever >39°C (Rectal Route). | 5 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Fever >39°C (Rectal Route). | 3 Participants |
| ACAC_Philippines Group | Number of Subjects With Fever >39°C (Rectal Route). | 40 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Fever >39°C (Rectal Route). | 24 Participants |
| HibACPS_Philippines Group | Number of Subjects With Fever >39°C (Rectal Route). | 17 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Fever >39°C (Rectal Route). | 6 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Population: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 99 Subjects |
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 12 Subjects |
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 168 Subjects |
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 18 Subjects |
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 95 Subjects |
| ACAC_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 57 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 33 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 14 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 5 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 78 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 33 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 33 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 55 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 12 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 33 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 3 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 8 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 14 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 16 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 4 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 1 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 1 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 26 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 151 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 51 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 1 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 10 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 42 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 40 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 13 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 6 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 69 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 33 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 32 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 22 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 49 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 21 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 1 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 21 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 3 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 10 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 8 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 9 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 22 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Day 0-3) follow-up period after vaccination
Population: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 96 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 149 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 7 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 6 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 21 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 146 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 1 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 98 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 55 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 110 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 113 Participants |
| ACAC_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 112 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 74 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 63 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 75 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 0 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 63 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 1 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 57 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 24 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 46 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 46 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 3 Participants |
| ACHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 0 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 7 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 53 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 47 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 2 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 0 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 19 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 41 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 33 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 2 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 53 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 33 Participants |
| HibACPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 41 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 0 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 17 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 17 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 26 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 5 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 26 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 15 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 1 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 15 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 7 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 1 Participants |
| HibHibPS_Thailand Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 18 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 5 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 29 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 80 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 4 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 3 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 116 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 53 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 1 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 72 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 16 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 34 Participants |
| ACAC_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 18 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 15 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 0 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 0 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 21 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 2 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 41 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 33 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 40 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 59 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 7 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 10 Participants |
| ACHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 2 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 35 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 39 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 6 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 24 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 0 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 4 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 2 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 2 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 23 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 5 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 3 Participants |
| HibACPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Drowsiness | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Loss of appetite | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Irritability | 17 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 40.0°C | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Loss of appetite | 0 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Grade 3 Irritability | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Irritability | 4 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Fever | 4 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Fever ≥ 38.5°C | 10 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Drowsiness | 8 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Related Drowsiness | 1 Participants |
| HibHibPS_Philippines Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Any Loss of appetite | 6 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-30) following booster vaccination
Population: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC_Thailand Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 64 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 23 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 24 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 9 Subjects |
| ACAC_Philippines Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 53 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 33 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 16 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 6 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
Population: This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC_Thailand Group | Number of Subjects With Serious Adverse Events (SAEs). | 3 Subjects |
| ACHibPS_Thailand Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| HibACPS_Thailand Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| HibHibPS_Thailand Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| ACAC_Philippines Group | Number of Subjects With Serious Adverse Events (SAEs). | 2 Subjects |
| ACHibPS_Philippines Group | Number of Subjects With Serious Adverse Events (SAEs). | 1 Subjects |
| HibACPS_Philippines Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| HibHibPS_Philippines Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |