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Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

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ClinicalTrials.gov Identifier: NCT01357720
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : May 22, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Prevention
Conditions Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Infections
Interventions Biological: Quinvaxem
Biological: Quinvaxem/Tritanrix
Enrollment 400
Recruitment Details

Participants were recruited at two vaccination sites in the Philippines:

First subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011

Pre-assignment Details  
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Period Title: Overall Study
Started 200 200
Completed 198 195
Not Completed 2 5
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem Total
Hide Arm/Group Description Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
<=18 years
200
 100.0%
200
 100.0%
400
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 200 participants 200 participants 400 participants
6.8  (0.91) 6.7  (0.86) 6.7  (0.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
101
  50.5%
105
  52.5%
206
  51.5%
Male
99
  49.5%
95
  47.5%
194
  48.5%
1.Primary Outcome
Title Seroprotection Rate: Anti-PRP Antibodies
Hide Description Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Time Frame 1 month after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Available observations at Visit 4
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description:
Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Number of Participants Analyzed 197 193
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100
(98.1 to 100)
100
(98.1 to 100)
2.Primary Outcome
Title Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Hide Description Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Time Frame 1 month after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Available observations at Visit 4
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description:
Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Number of Participants Analyzed 198 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
94.9
(90.9 to 97.6)
97.4
(94.1 to 99.2)
3.Primary Outcome
Title Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
Hide Description Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Time Frame 1 month after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Available observations at Visit 4
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description:
Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Number of Participants Analyzed 198 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
99.5
(97.2 to 100)
100
(98.1 to 100)
4.Primary Outcome
Title Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Hide Description Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Time Frame 1 month after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Available observations at Visit 4
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description:
Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Number of Participants Analyzed 198 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100
(98.2 to 100)
100
(98.1 to 100)
5.Primary Outcome
Title Seroprotection Rate: Anti-B. Pertussis Antibodies
Hide Description Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)
Time Frame 1 month after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Available observations at Visit 4
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description:
Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Number of Participants Analyzed 198 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
99.0
(96.4 to 99.9)
100
(98.1 to 100)
Time Frame Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Hide Arm/Group Description Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
All-Cause Mortality
Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/200 (0.00%)      2/200 (1.00%)    
Blood and lymphatic system disorders     
Idiopathic thrombocytopenic purpura  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Infections and infestations     
Viral encephalitis  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Pneumonia  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Quinvaxem Tritanrix Hib/HepB + Quinvaxem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   180/200 (90.00%)      180/200 (90.00%)    
General disorders     
Injection site pain  1  137/200 (68.50%)  293 157/200 (78.50%)  338
Injection site induration  1  74/200 (37.00%)  138 82/200 (41.00%)  145
Injection site erythema  1  59/200 (29.50%)  87 54/200 (27.00%)  73
Pyrexia  1  88/200 (44.00%)  133 95/200 (47.50%)  137
Infections and infestations     
Upper respiratory tract infection  1  46/200 (23.00%)  55 54/200 (27.00%)  69
Nasopharyngitis  1  7/200 (3.50%)  7 9/200 (4.50%)  10
Rhinitis  1  7/200 (3.50%)  8 7/200 (3.50%)  7
Pneumonia  1  7/200 (3.50%)  7 3/200 (1.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Any material for public dissemination will be submitted to the Sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Director
Organization: Crucell Switzerland AG
Phone: +41(0)319086111
EMail: info@crucell.com
Layout table for additonal information
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01357720     History of Changes
Other Study ID Numbers: QVX-V-A001
First Submitted: May 19, 2011
First Posted: May 23, 2011
Results First Submitted: March 27, 2013
Results First Posted: May 22, 2013
Last Update Posted: September 9, 2013