Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
Conditions
Brief summary
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.
Interventions
BIOLOGICALDTPa-HBV-IPV/Hib
1 intramuscular injection (3rd study vaccine dose)
BIOLOGICALDTPa-IPV/Hib vaccine
3 intramuscular injections (1st, 2nd and 4th vaccine dose)
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Weeks to 17 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have been enrolled in the Rota-028 study. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.
Exclusion criteria
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | During the 31-day (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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any Large Swelling Reactions | At Month 15, post-booster dose | A large swelling reaction was defined as swelling with a diameter greater than (\>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | During the entire study period (from Month 0 up to Month 21) | 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
Singapore
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 Hexa Group Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix in study 444563/028, additionally received 2 doses of Infanrix-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix-IPV/Hib vaccine (at 18 months of age). The Infanrix-IPV/Hib and Infanrix Hexa vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix vaccine was given orally. | 702 |
| Total | 702 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to follow-up(complete vacc. course) | 13 |
| Overall Study | Lost to follow-up(incompl. vacc. course) | 4 |
| Overall Study | Migrated/moved from study area | 1 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Infanrix Hexa Group |
|---|---|
| Age, Continuous | 13.5 Weeks STANDARD_DEVIATION 0.99 |
| Race/Ethnicity, Customized Chinese | 366 Participants |
| Race/Ethnicity, Customized Indian | 38 Participants |
| Race/Ethnicity, Customized Japanese | 1 Participants |
| Race/Ethnicity, Customized Malay | 269 Participants |
| Race/Ethnicity, Customized Not specified | 27 Participants |
| Race/Ethnicity, Customized White/Caucasian | 1 Participants |
| Sex: Female, Male Female | 349 Participants |
| Sex: Female, Male Male | 353 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 702 |
| other Total, other adverse events | 594 / 702 |
| serious Total, serious adverse events | 108 / 702 |
Outcome results
Primary
Number of Subjects Reporting Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 106 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary) (°C), Dose 3 | 100 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Irritability, Dose 3 | 161 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 106 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Drowsiness, Booster dose | 89 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary) (°C), Booster dose | 152 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Irritability, Booster dose | 163 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Loss of appetite, Booster dose | 118 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Drowsiness, Across doses | 290 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary) (°C), Across doses | 330 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Irritability, Across doses | 381 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Loss of appetite, Across doses | 324 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 165 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary) (°C), Dose 1 | 139 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Irritability, Dose 1 | 229 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 173 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 140 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary) (°C), Dose 2 | 124 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Irritability, Dose 2 | 192 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 155 Participants |
Primary
Number of Subjects Reporting Any Solicited Local Symptoms
Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Pain, Dose 1 | 130 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness, Dose 1 | 120 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling, Dose 1 | 89 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Pain, Dose 2 | 134 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness, Dose 2 | 137 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling, Dose 2 | 100 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Pain, Dose 3 | 97 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness, Dose 3 | 126 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling, Dose 3 | 100 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Pain, Booster dose | 166 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness, Booster dose | 148 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling, Booster dose | 115 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Pain, Across doses | 301 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness, Across doses | 273 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling, Across doses | 215 Participants |
Secondary
Number of Subjects Reporting Any Large Swelling Reactions
A large swelling reaction was defined as swelling with a diameter greater than (\>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.
Time frame: At Month 15, post-booster dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects Reporting Any Large Swelling Reactions | 0 Participants |
Secondary
Number of Subjects Reporting Any 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 entire study period (from Month 0 up to Month 21)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 108 Participants |
Secondary
Number of Subjects Reporting Any 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) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 321 Participants |