Trial Outcomes & Findings for Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers (NCT NCT01577732)

Results Overview

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

321 participants

Primary outcome timeframe

Within the 4-day (Days 0-3) follow up period after vaccination.

Results posted on

2020-01-21

Participant Flow

321 subjects were screened and allocated a subject number for the study, out of which 300 participated in the study and received the study vaccination.

Participant milestones

Participant milestones
Measure	Infanrix-IPV+Hib Group Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infanrix-IPV+Hib Group n=300 Participants Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Age, Continuous	15.8 months STANDARD_DEVIATION 2.96 • n=5 Participants
Sex: Female, Male Female	143 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	300 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the 4-day (Days 0-3) follow up period after vaccination.

Population: Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Infanrix-IPV+Hib Group n=300 Participants Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects Reporting Solicited Local Symptoms Any Pain	95 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Redness	82 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Swelling	52 Participants

PRIMARY outcome

Timeframe: Within the 4-day (Days 0-3) follow up period after vaccination.

Population: Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.

Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Infanrix-IPV+Hib Group n=300 Participants Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects Reporting Solicited General Symptoms Any Drowsiness	52 Participants
Number of Subjects Reporting Solicited General Symptoms Any Irritability/fussiness	108 Participants
Number of Subjects Reporting Solicited General Symptoms Any Loss of appetite	115 Participants
Number of Subjects Reporting Solicited General Symptoms Any Fever	101 Participants

PRIMARY outcome

Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.

Population: Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.

An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Infanrix-IPV+Hib Group n=300 Participants Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	107 Participants

PRIMARY outcome

Timeframe: During the entire study period (Days 0-30).

Population: Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.

SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Infanrix-IPV+Hib Group n=300 Participants Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).	1 Participants

Adverse Events

Infanrix-IPV+Hib Group

Serious events: 1 serious events

Other events: 211 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infanrix-IPV+Hib Group n=300 participants at risk Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Nervous system disorders Convulsion	0.33% 1/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
Infections and infestations Pneumonia	0.33% 1/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).

Other adverse events

Other adverse events
Measure	Infanrix-IPV+Hib Group n=300 participants at risk Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
General disorders Pain	31.7% 95/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Redness	27.3% 82/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Swelling	17.3% 52/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Drowsiness	17.3% 52/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Irritability/fussiness	36.0% 108/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Loss of appetite	38.3% 115/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
General disorders Fever	33.7% 101/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
Respiratory, thoracic and mediastinal disorders Cough	16.0% 48/300 • Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).

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