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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00325156
First received: February 8, 2006
Last updated: November 8, 2012
Last verified: November 2012

February 8, 2006
November 8, 2012
November 2004
August 2007   (final data collection date for primary outcome measure)
Occurrence of solicited local and general adverse events [ Time Frame: During the 4-day follow up period after vaccination ] [ Designated as safety issue: Yes ]
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
  • Occurrence of unsolicited local and general adverse events [ Time Frame: During the 30-day follow up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of large swelling reactions [ Time Frame: After booster dose ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events. [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria, Tetanus, Pertussis, Poliomyelitis & Haemophilus Influenzae Type b Disease
  • Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
Other Name: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Experimental: Group A
Intervention: Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Lim FS et al. (2011) Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 42(1):138-147.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2590
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.
Both
11 Weeks to 17 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00325156
100917
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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