Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines, Haemophilus Influenzae Type b, Poliomyelitis, Tetanus
Conditions
Keywords
booster, Infanrix-IPV+HibTM, DTPa-IPV/Hib, Vietnamese toddlers
Brief summary
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.
Interventions
BIOLOGICALInfanrix-IPV+Hib™
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that 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, 12 and 24 months of age at the time of vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * 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. * Evidence of previous or intercurrent booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination. * History of any neurological disorders or seizures. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Local Symptoms | Within the 4-day (Days 0-3) follow up period after vaccination. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Solicited General Symptoms | Within the 4-day (Days 0-3) follow up period after vaccination. | 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. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | Within the 31-day (Days 0-30) follow up period after vaccination. | 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. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs). | During the entire study period (Days 0-30). | 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. |
Countries
Vietnam
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | Infanrix-IPV+Hib Group |
|---|---|
| Age, Continuous | 15.8 months STANDARD_DEVIATION 2.96 |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 300 Participants |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 211 / 300 |
| serious Total, serious adverse events | 1 / 300 |
Outcome results
Primary
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | 1 Participants |
Primary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 107 Participants |
Primary
Number of Subjects Reporting Solicited General Symptoms
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness | 52 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability/fussiness | 108 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite | 115 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever | 101 Participants |
Primary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness | 82 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling | 52 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain | 95 Participants |