Trial Outcomes & Findings for Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children (NCT NCT01988857)

NCT ID: NCT01988857

Last Updated: 2018-08-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

302 participants

Primary outcome timeframe

Within 4 days (Days 0-3) post vaccination period

Results posted on

2018-08-02

Participant Flow

Out of the 302 subjects enrolled into the study, 2 were excluded due to developing allergic reactions and hence only 300 started the study.

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Boostrix Group Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boostrix Group n=300 Participants Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Age, Categorical <=18 years	300 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7.9 Years STANDARD_DEVIATION 1.38 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	300 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 4 days (Days 0-3) post vaccination period

Outcome measures

Outcome measures
Measure	Boostrix Group n=300 Participants Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	105 Participants
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	55 Participants
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	40 Participants
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	1 Participants
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	1 Participants
Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Boostrix Group n=300 Participants Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	33 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Boostrix Group n=300 Participants Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	19 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Boostrix Group n=300 Participants Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants

Adverse Events

Boostrix Group

Serious events: 0 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Boostrix Group n=300 participants at risk Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
General disorders Pain	35.0% 105/300 • 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).
General disorders Redness	18.3% 55/300 • 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).
General disorders Swelling	13.3% 40/300 • 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).
General disorders Fatigue	14.0% 42/300 • 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).
General disorders Gastrointestinal symptoms	5.0% 15/300 • 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).
General disorders Headache	11.0% 33/300 • 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).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER