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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

Primary Purpose

Diphtheria, Tetanus, Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
GSK Biologicals' combined DTPa-IPV/Hib vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

11 Weeks - 17 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Any Solicited Local and General Symptoms
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)
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
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)
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.

Full Information

First Posted
February 8, 2006
Last Updated
December 26, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00325156
Brief Title
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2004 (Actual)
Primary Completion Date
August 23, 2007 (Actual)
Study Completion Date
August 23, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' combined DTPa-IPV/Hib vaccine
Intervention Description
4 intramuscular injections
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any Solicited Local and General Symptoms
Description
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.
Time Frame
During the 4-day (Days 0-3) post-vaccination period, across doses
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 30-day (Days 0-29) post-vaccination period
Title
Number of Subjects Reporting Large Injection Site Swelling
Description
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.
Time Frame
At Month 18, post-booster dose
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
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.
Time Frame
During the entire study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Weeks
Maximum Age & Unit of Time
17 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=350
Citations:
PubMed Identifier
21323176
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100917
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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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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