Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Study Overview
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Brief Summary
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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
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Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Official Title
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Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

Conditions
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Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis

Intervention / Treatment
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* Biological: DTPa-HBV-IPV/Hib
* Biological: DTPa-IPV/Hib vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Weeks
Maximum Age: 17 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infanrix Hexa Group<br>Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), 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. | Biological: DTPa-HBV-IPV/Hib<br>* 1 intramuscular injection (3rd study vaccine dose)<br>* Other names: INFANRIX HEXA™;Biological: DTPa-IPV/Hib vaccine<br>* 3 intramuscular injections (1st, 2nd and 4th vaccine dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | 
| 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. | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the 31-day (Days 0-30) post-vaccination period | 
| 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. | At Month 15, post-booster dose | 
| 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. | During the entire study period (from Month 0 up to Month 21) |