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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: December 14, 2016
Last verified: November 2016
  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
Poliomyelitis
Acellular Pertussis
Haemophilus Influenzae Type b
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

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   (Child)
Sexes Eligible for Study:   All
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

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100917
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00325156     History of Changes
Other Study ID Numbers: 100917
Study First Received: February 8, 2006
Results First Received: December 14, 2016
Last Updated: December 14, 2016
Individual Participant Data  
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.

Additional relevant MeSH terms:
Poliomyelitis
Diphtheria
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017