Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Market Surveillance for Infanrix™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908115
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 17, 2009
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Diphtheria
Acellular Pertussis
Tetanus
Intervention Biological: GSK Biologicals' Infanrix™
Enrollment 1258
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infanrix Group
Hide Arm/Group Description Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Period Title: Overall Study
Started 1258
Completed 1244
Not Completed 14
Reason Not Completed
Other             14
Arm/Group Title Infanrix Group
Hide Arm/Group Description Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Overall Number of Baseline Participants 1258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1258 participants
5.0  (8.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1258 participants
Female
615
  48.9%
Male
643
  51.1%
1.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame Since the beginning of the study and during the entire study period (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infanrix Group
Hide Arm/Group Description:
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Overall Number of Participants Analyzed 1258
Measure Type: Number
Unit of Measure: Subjects
3
2.Primary Outcome
Title Number of Subjects Reporting Solicited Symptoms
Hide Description Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
Time Frame During the 4-week follow-up period after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subjects who received the considered dose.
Arm/Group Title Infanrix Group
Hide Arm/Group Description:
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Overall Number of Participants Analyzed 877
Measure Type: Number
Unit of Measure: Subjects
Induration after Dose 1 (n=798) 51
Induration after Dose 2 (n=843) 72
Induration after Dose 3 (n=877) 86
Induration after Booster at 15-18 Months (n=88) 19
Induration after Booster at 4-6 Years (n=22) 5
Itching after Dose 1 (n=798) 5
Itching after Dose 2 (n=843) 8
Itching after Dose 3 (n=877) 2
Itching after Booster at 15-18 Months (n=88) 8
Itching after Booster at 4-6 Years (n=22) 4
Pain after Dose 1 (n=798) 29
Pain after Dose 2 (n=843) 31
Pain after Dose 3 (n=877) 43
Pain after Booster at 15-18 Months (n=88) 13
Pain after Booster at 4-6 Years (n=22) 6
Redness after Dose 1 (n=798) 51
Redness after Dose 2 (n=843) 76
Redness after Dose 3 (n=877) 79
Redness after Booster at 15-18 Months (n=88) 22
Redness after Booster at 4-6 Years (n=22) 4
Swelling after Dose 1 (n=798) 26
Swelling after Dose 2 (n=843) 43
Swelling after Dose 3 (n=877) 51
Swelling after Booster at 15-18 Months (n=88) 20
Swelling after Booster at 4-6 Years (n=22) 5
Anorexia after Dose 1 (n=798) 41
Anorexia after Dose 2 (n=843) 40
Anorexia after Dose 3 (n=877) 31
Anorexia after Booster at 15-18 Months (n=88) 5
Anorexia after Booster at 4-6 Years (n=22) 0
Convulsions after Dose 1 (n=798) 1
Convulsions after Dose 2 (n=843) 1
Convulsions after Dose 3 (n=877) 2
Convulsions after Booster at 15-18 Months (n=88) 0
Convulsions after Booster at 4-6 Years (n=22) 0
Cough after Dose 1 (n=798) 21
Cough after Dose 2 (n=843) 18
Cough after Dose 3 (n=877) 20
Cough after Booster at 15-18 Months (n=88) 3
Cough after Booster at 4-6 Years (n=22) 0
Diarrhea after Dose 1 (n=798) 15
Diarrhea after Dose 2 (n=843) 15
Diarrhea after Dose 3 (n=877) 20
Diarrhea after Booster at 15-18 Months (n=88) 4
Diarrhea after Booster at 4-6 Years (n=22) 0
Drowsiness after Dose 1 (n=798) 47
Drowsiness after Dose 2 (n=843) 41
Drowsiness after Dose 3 (n=877) 38
Drowsiness after Booster at 15-18 Months (n=88) 5
Drowsiness after Booster at 4-6 Years (n=22) 1
Eruption after Dose 1 (n=798) 6
Eruption after Dose 2 (n=843) 7
Eruption after Dose 3 (n=877) 13
Eruption after Booster at 15-18 Months (n=88) 2
Eruption after Booster at 4-6 Years (n=22) 0
Fever after Dose 1 (n=798) 40
Fever after Dose 2 (n=843) 36
Fever after Dose 3 (n=877) 17
Fever after Booster at 15-18 Months (n=88) 6
Fever after Booster at 4-6 Years (n=22) 2
Irritability after Dose 1 (n=798) 90
Irritability after Dose 2 (n=843) 82
Irritability after Dose 3 (n=877) 74
Irritability after Booster at 15-18 Months (n=88) 9
Irritability after Booster at 4-6 Years (n=22) 1
Vomiting after Dose 1 (n=798) 20
Vomiting after Dose 2 (n=843) 13
Vomiting after Dose 3 (n=877) 13
Vomiting after Booster at 15-18 Months (n=88) 1
Vomiting after Booster at 4-6 Years (n=22) 0
3.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description An adverse event is 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.
Time Frame Within the 31-day (Day 0-30) following vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infanrix Group
Hide Arm/Group Description:
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Overall Number of Participants Analyzed 1258
Measure Type: Number
Unit of Measure: Subjects
144
Time Frame SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
Adverse Event Reporting Description For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
 
Arm/Group Title Infanrix Group
Hide Arm/Group Description Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
All-Cause Mortality
Infanrix Group
Affected / at Risk (%)
Total   0/1258 (0.00%) 
Hide Serious Adverse Events
Infanrix Group
Affected / at Risk (%)
Total   3/1258 (0.24%) 
Infections and infestations   
Croup infectious *  1/1258 (0.08%) 
Gastroenteritis *  1/1258 (0.08%) 
Urinary tract infection *  1/1258 (0.08%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infanrix Group
Affected / at Risk (%)
Total   90/877 (10.26%) 
General disorders   
Induration PRI D1  [1]  51/798 (6.39%) 
Induration PRI D2  [1]  72/843 (8.54%) 
Induration PRI D3  [1]  86/877 (9.81%) 
Redness PRI D1  [1]  51/798 (6.39%) 
Redness PRI D2  [1]  76/843 (9.02%) 
Redness PRI D3  [1]  79/877 (9.01%) 
Swelling PRI D2  [1]  43/843 (5.10%) 
Drowsiness PRI D1  [1]  47/798 (5.89%) 
Irritability PRI D1  [1]  90/798 (11.28%) 
Irritability PRI D2  [1]  82/843 (9.73%) 
Irritability PRI D3  [1]  74/877 (8.44%) 
Swelling PRI D3   51/877 (5.82%) 
Induration BST 15-18M   19/88 (21.59%) 
Itching BST 15-18M   8/88 (9.09%) 
Pain BST 15-18M   13/88 (14.77%) 
Redness BST 15-18M   22/88 (25.00%) 
Swelling BST 15-18M   20/88 (22.73%) 
Induration BST 4-6Y   5/22 (22.73%) 
Itching BST 4-6Y   4/22 (18.18%) 
Pain BST 4-6Y   6/22 (27.27%) 
Redness BST 4-6Y   4/22 (18.18%) 
Swelling BST 4-6Y   5/22 (22.73%) 
Anorexia PRI D1   41/798 (5.14%) 
Fever PRI D1   40/798 (5.01%) 
Anorexia BST 15-18M   5/88 (5.68%) 
Drowsiness BST 15-18M   5/88 (5.68%) 
Fever BST 15-18M   6/88 (6.82%) 
Irritability BST 15-18M   9/88 (10.23%) 
Fever BST 4-6Y   2/22 (9.09%) 
Indicates events were collected by systematic assessment
[1]
The number of subjects at risk is the total number of subjects that received the respective dose.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00908115    
Other Study ID Numbers: 208355/128
First Submitted: May 21, 2009
First Posted: May 25, 2009
Results First Submitted: May 28, 2009
Results First Posted: July 17, 2009
Last Update Posted: January 2, 2020