Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
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.
|Diphtheria Tetanus Poliomyelitis Acellular Pertussis Haemophilus Influenzae Type b||Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants.|
- Number of Subjects Reporting Any Solicited Local and General Symptoms [ Time Frame: 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.
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
|Study Start Date:||November 2004|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Experimental: Group A||
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325156
|GSK Investigational Site|
|Singapore, Singapore, 308433|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|