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Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00325156
Recruitment Status : Completed
First Posted : May 12, 2006
Results First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):

February 8, 2006
May 12, 2006
December 14, 2016
February 7, 2017
February 7, 2017
November 2004
August 2007   (Final data collection date for primary outcome measure)
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.
Occurrence of solicited adverse events during the 4-day follow up period
Complete list of historical versions of study NCT00325156 on ClinicalTrials.gov Archive Site
  • 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.
Occurrence of unsolicited adverse events during the 31-day follow up period, large swelling reactions after booster dose and serious adverse events during the entire study period
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Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
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.

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.

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
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Poliomyelitis
  • Acellular Pertussis
  • Haemophilus Influenzae Type b
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
Experimental: Group A
Intervention: Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2007
August 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
11 Weeks to 17 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP