Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
Study Details
Study Description
Brief Summary
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period).
This protocol summary was updated following an administrative change of adding the EudraCT number to this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: dTpa Group
|
Biological: Boostrix™
Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
|
Outcome Measures
Primary Outcome Measures
- Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms [Within 4 days (Days 0-3) post vaccination period]
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 100 millimeters (mm) of injection site. Relationship analysis was not performed.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within 4 days (Days 0-3) post vaccination period]
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
- Number of Subjects With Unsolicited Adverse Events (AEs) [Within 31 days (Days 0-30) post vaccination period]
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.
- Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (From Day 0 to Day 30)]
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
Inclusion Criteria:
-
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
-
A male or female between, and including, 6 and 10 years of age at the time of the vaccination.
-
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
-
Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s), as required by local regulations.
-
Healthy subjects as established by medical history and clinical examination before entering into the study.
-
Subjects who have previously completed their routine vaccinations against diphtheria, tetanus and pertussis diseases according to the local recommended vaccination schedule at that time and have not received the vaccine in the last two years prior to study dose administration.
-
Female subjects of non-childbearing potential may be enrolled in the study.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-
has practiced abstinence or adequate contraception for 30 days prior to vaccination, and
-
has a negative pregnancy test on the day of vaccination, and
-
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
-
Child in care.
-
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
-
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Inhaled and topical steroids are allowed.
-
Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccine dose, or planned administration during the study period.
-
Administration of immunoglobulins and/or any blood products within the three months preceding Visit 1 or planned administration during the study period.
-
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
-
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
-
A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
-
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-
Major congenital defects or serious chronic illness.
-
Acute disease and/or fever at the time of enrollment.
-
Pregnant or lactating female.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Hanoi | Vietnam | 084 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 115739
- 2013-003859-37
Study Results
Participant Flow
| Recruitment Details | Out of the 302 subjects enrolled into the study, 2 were excluded due to developing allergic reactions and hence only 300 started the study. |
|---|---|
| Pre-assignment Detail | During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. |
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Period Title: Overall Study | |
| STARTED | 300 |
| COMPLETED | 300 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Overall Participants | 300 |
| Age (Count of Participants) | |
| <=18 years |
300
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
7.9
(1.38)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
151
50.3%
|
| Male |
149
49.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian - South East Asian Heritage |
300
100%
|
Outcome Measures
| Title | Numbers 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 100 millimeters (mm) of injection site. Relationship analysis was not performed. |
| Time Frame | Within 4 days (Days 0-3) post vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Measure Participants | 300 |
| Any Pain |
105
35%
|
| Any Redness |
55
18.3%
|
| Any Swelling |
40
13.3%
|
| Grade 3 Pain |
1
0.3%
|
| Grade 3 Redness |
1
0.3%
|
| Grade 3 Swelling |
3
1%
|
| Title | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
|---|---|
| Description | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Time Frame | Within 4 days (Days 0-3) post vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Measure Participants | 300 |
| Any Fatigue |
42
14%
|
| Any Gastrointestinal symptoms |
15
5%
|
| Any Headache |
33
11%
|
| Any Temperature |
14
4.7%
|
| Grade 3 Fatigue |
1
0.3%
|
| Grade 3 Gastrointestinal symptoms |
0
0%
|
| Grade 3 Headache |
0
0%
|
| Grade 3 Temperature |
0
0%
|
| Related Fatigue |
40
13.3%
|
| Related Gastrointestinal symptoms |
14
4.7%
|
| Related Headache |
33
11%
|
| Related Temperature |
13
4.3%
|
| Title | Number of Subjects With 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. |
| Time Frame | Within 31 days (Days 0-30) post vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Measure Participants | 300 |
| Count of Participants [Participants] |
19
6.3%
|
| 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 | During the entire study period (From Day 0 to Day 30) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Boostrix Group |
|---|---|
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
| Measure Participants | 300 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | Solicited symptoms during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period, SAEs during the entire study period (from Day 0 to Day 30). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Boostrix Group | |
| Arm/Group Description | Subjects received a single dose of Boostrix vaccine at 6-10 years of age. | |
All Cause Mortality |
||
| Boostrix Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Serious Adverse Events |
||
| Boostrix Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Boostrix Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 133/300 (44.3%) | |
| General disorders | ||
| Pain | 105/300 (35%) | |
| Redness | 55/300 (18.3%) | |
| Swelling | 40/300 (13.3%) | |
| Fatigue | 42/300 (14%) | |
| Gastrointestinal symptoms | 15/300 (5%) | |
| Headache | 33/300 (11%) | |
Limitations/Caveats
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 |
- 115739
- 2013-003859-37