Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines, Haemophilus Influenzae Type b, Poliomyelitis, Tetanus
Conditions
Brief summary
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The 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. 3-4-5 month schedule with a booster dose at 18 months
Interventions
BIOLOGICALGSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
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. * 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 for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
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 and General Symptoms | During the 4-day (Days 0-3) post-vaccination period, across doses | Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) 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 Large Injection Site Swelling | At Month 18, 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 | 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-IPV+ Hib Group Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age. | 2,590 |
| Total | 2,590 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse event, non-fatal | 3 |
| Overall Study | Lost to follow-up (complete vaccination) | 41 |
| Overall Study | Lost to follow-up (incompl. vaccination) | 16 |
| Overall Study | Migrated/moved from study area | 12 |
| Overall Study | Other | 1 |
| Overall Study | Protocol Violation | 8 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | Infanrix-IPV+ Hib Group |
|---|---|
| Age, Continuous | 13.3 Weeks STANDARD_DEVIATION 0.87 |
| Sex: Female, Male Female | 1245 Participants |
| Sex: Female, Male Male | 1345 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2,167 / 2,590 |
| serious Total, serious adverse events | 380 / 2,590 |
Outcome results
Primary
Number of Subjects Reporting Any Solicited Local and General Symptoms
Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period, across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Pain, Across doses | 855 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Redness, Across doses | 907 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Swelling, Across doses | 706 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Drowsiness, Across doses | 929 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Fever (Axillary/≥ 37.5°C), Across doses | 1482 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Irritability, Across doses | 1217 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Solicited Local and General Symptoms | Any Loss of appetite, Across doses | 1010 Subjects |
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 380 Subjects |
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 30-day (Days 0-29) 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 (NUMBER) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 914 Subjects |
Secondary
Number of Subjects Reporting Large Injection Site Swelling
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 18, post-booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Large Injection Site Swelling | Local swelling | 10 Subjects |
| Infanrix-IPV+Hib Group | Number of Subjects Reporting Large Injection Site Swelling | Diffuse swelling | 1 Subjects |