Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00228917
Collaborator
(none)
798
2
8
7.2
399
55.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
798 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)
Actual Study Start Date
:
Jun 16, 2005
Actual Primary Completion Date
:
Jan 20, 2006
Actual Study Completion Date
:
Jan 20, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ACAC_Thailand Group Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are 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 |
Biological: Tritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
|
| Experimental: ACHibPS_Thailand Group Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are 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 are 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 |
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
| Experimental: HibACPS_Thailand Group Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated 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 are 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 |
Biological: Tritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
| Experimental: HibHibPS_Thailand Group Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are 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 are 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 |
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
| Experimental: ACAC_Philippines Group Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are 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 |
Biological: Tritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
|
| Experimental: ACHibPS_Philippines Group Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are 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 are 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 |
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
| Experimental: HibACPS_Philippines Group Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are 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 are 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 |
Biological: Tritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
| Experimental: HibHibPS_Philippines Group Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are 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 are 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 |
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
427 Days
to 577 Days
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Muntinlupa | Philippines | 1781 | |
| 2 | GSK Investigational Site | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00228917
Other Study ID Numbers:
- 103812
- 104171
First Posted:
Sep 29, 2005
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Period Title: Overall Study | ||||||||
| STARTED | 193 | 96 | 65 | 33 | 205 | 104 | 69 | 33 |
| COMPLETED | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 193 | 96 | 65 | 33 | 205 | 104 | 69 | 33 | 798 |
| Age (Months) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [Months] |
17.7
(0.7)
|
17.8
(0.71)
|
17.7
(0.78)
|
17.6
(0.7)
|
17.1
(0.78)
|
17.2
(0.79)
|
17.2
(0.93)
|
17
(0.77)
|
17.59
(0.76)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
96
49.7%
|
45
46.9%
|
32
49.2%
|
18
54.5%
|
107
52.2%
|
56
53.8%
|
29
42%
|
16
48.5%
|
399
50%
|
| Male |
97
50.3%
|
51
53.1%
|
33
50.8%
|
15
45.5%
|
98
47.8%
|
48
46.2%
|
40
58%
|
17
51.5%
|
399
50%
|
Outcome Measures
| Title | Number of Subjects With Fever >39°C (Rectal Route). |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Measure Participants | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| Count of Participants [Participants] |
22
11.4%
|
8
8.3%
|
5
7.7%
|
3
9.1%
|
40
19.5%
|
24
23.1%
|
17
24.6%
|
6
18.2%
|
| Title | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Measure Participants | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| Any Drowsiness |
113
58.5%
|
63
65.6%
|
41
63.1%
|
17
51.5%
|
53
25.9%
|
33
31.7%
|
23
33.3%
|
8
24.2%
|
| Grade 3 Drowsiness |
6
3.1%
|
0
0%
|
0
0%
|
0
0%
|
3
1.5%
|
0
0%
|
2
2.9%
|
1
3%
|
| Related Drowsiness |
110
57%
|
63
65.6%
|
41
63.1%
|
17
51.5%
|
16
7.8%
|
7
6.7%
|
4
5.8%
|
1
3%
|
| Any Irritability |
149
77.2%
|
75
78.1%
|
53
81.5%
|
26
78.8%
|
116
56.6%
|
59
56.7%
|
39
56.5%
|
17
51.5%
|
| Grade 3 Irritability |
21
10.9%
|
3
3.1%
|
7
10.8%
|
5
15.2%
|
4
2%
|
2
1.9%
|
1
1.4%
|
1
3%
|
| Related Irritability |
146
75.6%
|
74
77.1%
|
53
81.5%
|
26
78.8%
|
29
14.1%
|
15
14.4%
|
6
8.7%
|
4
12.1%
|
| Any Loss of appetite |
98
50.8%
|
46
47.9%
|
33
50.8%
|
15
45.5%
|
72
35.1%
|
40
38.5%
|
24
34.8%
|
6
18.2%
|
| Grade 3 Loss of appetite |
7
3.6%
|
1
1%
|
2
3.1%
|
1
3%
|
1
0.5%
|
0
0%
|
0
0%
|
0
0%
|
| Related Loss of appetite |
96
49.7%
|
46
47.9%
|
33
50.8%
|
15
45.5%
|
18
8.8%
|
10
9.6%
|
2
2.9%
|
1
3%
|
| Fever ≥ 38.5°C |
55
28.5%
|
24
25%
|
19
29.2%
|
7
21.2%
|
80
39%
|
41
39.4%
|
35
50.7%
|
10
30.3%
|
| Fever ≥ 40.0°C |
1
0.5%
|
0
0%
|
2
3.1%
|
1
3%
|
5
2.4%
|
2
1.9%
|
3
4.3%
|
1
3%
|
| Related Fever |
112
58%
|
57
59.4%
|
47
72.3%
|
18
54.5%
|
34
16.6%
|
21
20.2%
|
5
7.2%
|
4
12.1%
|
| Title | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Measure Participants | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| Any Pain |
168
|
78
|
55
|
26
|
151
|
69
|
49
|
22
|
| Grade 3 Pain |
57
|
14
|
12
|
4
|
42
|
13
|
22
|
8
|
| Any Redness |
99
|
33
|
33
|
16
|
40
|
33
|
21
|
9
|
| Grade 3 Redness |
12
|
0
|
3
|
1
|
1
|
0
|
1
|
0
|
| Any Swelling |
95
|
33
|
33
|
14
|
51
|
32
|
21
|
10
|
| Grade 3 Swelling |
18
|
5
|
8
|
1
|
10
|
6
|
3
|
0
|
| Title | Number of Subjects With Any Unsolicited Adverse Events (AEs). |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Measure Participants | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| Number [Subjects] |
64
|
23
|
24
|
9
|
53
|
33
|
16
|
6
|
| Title | Number of Subjects With Serious Adverse Events (SAEs). |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACAC_Thailand Group | ACHibPS_Thailand Group | HibACPS_Thailand Group | HibHibPS_Thailand Group | ACAC_Philippines Group | ACHibPS_Philippines Group | HibACPS_Philippines Group | HibHibPS_Philippines Group |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. |
| Measure Participants | 193 | 96 | 65 | 33 | 205 | 102 | 69 | 33 |
| Number [Subjects] |
3
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
Adverse Events
| Time Frame | Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups | |||||||
| Arm/Group Title | ACAC Group | ACHibPS Group | HibACPS Group | HibHibPS Group | ||||
| Arm/Group Description | Subjects from both ACAC_Thailand and ACAC_Philippines groups | Subjects from both ACHibPS_Thailand and ACHibPS_Philippines groups | Subjects from both HibACPS_Thailand and HibACPS_Philippines groups | Subjects from both HibHibPS _Thailand and HibHibPS _Philippines groups | ||||
All Cause Mortality |
||||||||
| ACAC Group | ACHibPS Group | HibACPS Group | HibHibPS Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/398 (0%) | 0/200 (0%) | 0/134 (0%) | 0/66 (0%) | ||||
Serious Adverse Events |
||||||||
| ACAC Group | ACHibPS Group | HibACPS Group | HibHibPS Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/398 (1.3%) | 1/200 (0.5%) | 0/134 (0%) | 0/66 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 1/398 (0.3%) | 0/200 (0%) | 0/134 (0%) | 0/66 (0%) | ||||
| Infections and infestations | ||||||||
| Pharyngitis | 1/398 (0.3%) | 0/200 (0%) | 0/134 (0%) | 0/66 (0%) | ||||
| Measles | 0/398 (0%) | 1/200 (0.5%) | 0/134 (0%) | 0/66 (0%) | ||||
| Upper respiratory tract infection | 1/398 (0.3%) | 0/200 (0%) | 0/134 (0%) | 0/66 (0%) | ||||
| Pneumonia | 1/398 (0.3%) | 0/200 (0%) | 0/134 (0%) | 0/66 (0%) | ||||
| Nervous system disorders | ||||||||
| Febrile convulsion | 2/398 (0.5%) | 1/200 (0.5%) | 0/134 (0%) | 0/66 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| ACAC Group | ACHibPS Group | HibACPS Group | HibHibPS Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 376/398 (94.5%) | 181/200 (90.5%) | 129/134 (96.3%) | 60/66 (90.9%) | ||||
| General disorders | ||||||||
| Pain | 319/398 (80.2%) | 147/200 (73.5%) | 104/134 (77.6%) | 48/66 (72.7%) | ||||
| Swelling | 146/398 (36.7%) | 65/200 (32.5%) | 54/134 (40.3%) | 24/66 (36.4%) | ||||
| Pyrexia | 272/398 (68.3%) | 126/200 (63%) | 99/134 (73.9%) | 41/66 (62.1%) | ||||
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 36/398 (9%) | 16/200 (8%) | 9/134 (6.7%) | 4/66 (6.1%) | ||||
| Nasopharyngitis | 10/398 (2.5%) | 4/200 (2%) | 8/134 (6%) | 2/66 (3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 170/398 (42.7%) | 86/200 (43%) | 57/134 (42.5%) | 21/66 (31.8%) | ||||
| Nervous system disorders | ||||||||
| Somnolence | 166/398 (41.7%) | 96/200 (48%) | 64/134 (47.8%) | 25/66 (37.9%) | ||||
| Psychiatric disorders | ||||||||
| Irritability | 265/398 (66.6%) | 134/200 (67%) | 92/134 (68.7%) | 43/66 (65.2%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Erythema | 139/398 (34.9%) | 66/200 (33%) | 54/134 (40.3%) | 25/66 (37.9%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00228917
Other Study ID Numbers:
- 103812
- 104171
First Posted:
Sep 29, 2005
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020