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
  Purpose

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.


Condition Intervention Phase
Diphtheria, Tetanus, Pertussis, Poliomyelitis & Haemophilus Influenzae Type b Disease
Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general adverse events [ Time Frame: During the 4-day follow up period after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2590
Study Start Date: November 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
Other Name: GSK Biologicals' combined DTPa-IPV/Hib vaccine

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

  Eligibility

Ages Eligible for Study:   11 Weeks to 17 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325156

Locations
Singapore
GSK Investigational Site
Singapore, Singapore, 308433
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00325156     History of Changes
Other Study ID Numbers: 100917
Study First Received: February 8, 2006
Last Updated: November 8, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diphtheria
Poliomyelitis
Tetanus
Actinomycetales Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Clostridium Infections
Corynebacterium Infections
Enterovirus Infections
Gram-Positive Bacterial Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014