Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
Conditions
Keywords
Combined vaccine
Brief summary
This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
Interventions
BIOLOGICALInfanrix™-IPV/Hib
Intramuscular, three doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit. * Born after a gestation period of 36 to 42 weeks inclusive. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine. * 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 diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease. * Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases. * History of seizures or progressive neurological disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) follow-up period after each dose and across doses | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period after each 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) | During the whole study period (from Day 0 until Month 3 or Month 4) | 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. |
Countries
China
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Infanrix-IPV/Hib M2-M3-M4 Group Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh. | 25 |
| Infanrix-IPV/Hib M3-M4-M5 Group Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Infanrix-IPV/Hib M3-M4-M5 Group | Total | Infanrix-IPV/Hib M2-M3-M4 Group |
|---|---|---|---|
| Age, Continuous | 14.2 Weeks STANDARD_DEVIATION 1.18 | 12.15 Weeks STANDARD_DEVIATION 2.42 | 10.1 Weeks STANDARD_DEVIATION 1.36 |
| Race/Ethnicity, Customized Asian-East Asian heritage | 25 Participants | 49 Participants | 24 Participants |
| Race/Ethnicity, Customized Asian-Japanese heritage | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 23 / 25 | 16 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
Time frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 9 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1 | 9 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 7 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1 | 8 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 3 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2 | 6 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 3 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2 | 5 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3 | 5 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 3 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3 | 7 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across doses | 12 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across doses | 15 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Across doses | 9 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across doses | 13 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Across doses | 12 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1 | 5 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across doses | 5 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3 | 4 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 1 | 8 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Across doses | 4 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 5 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2 | 3 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across doses | 8 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 3 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 3 | 3 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever, Dose 2 | 5 Participants |
Primary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 1 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 0 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 4 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 4 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 2 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 1 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 3 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
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 whole study period (from Day 0 until Month 3 or Month 4)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
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 (Days 0-30) follow-up period after each vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV/Hib M2-M3-M4 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 16 Participants |
| Infanrix-IPV/Hib M3-M4-M5 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 1 Participants |