Back to resultsComparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Primary Purpose
Hepatitis B, Polio, Diphtheria
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
Eligibility Criteria
Inclusion Criteria :
- Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
- Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.
- Hepatitis B vaccination since birth.
- Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received since birth.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Any planned vaccination (except trial vaccinations) during the trial.
- Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
- Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- History of seizures.
- Febrile (rectal equivalent temperature >= 38.0°C) or acute illness on the day of inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: DTaP IPV Hep B PRP T + Prevnar™
Group 2: Infanrix hexa™ + Prevnar™
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Secondary Outcome Measures
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.
Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Full Information
NCT ID
NCT00401531
First Posted
November 16, 2006
Last Updated
February 14, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00401531
Brief Title
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Official Title
Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Polio, Diphtheria, Pertussis, Haemophilus Influenzae Type b
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: DTaP IPV Hep B PRP T + Prevnar™
Arm Type
Experimental
Arm Title
Group 2: Infanrix hexa™ + Prevnar™
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Other Intervention Name(s)
Prevnar®
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Other Intervention Name(s)
Infanrix™-Hexa, Prevnar®
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Time Frame
Day 150 post-dose 1
Secondary Outcome Measure Information:
Title
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Time Frame
Day 150 post-dose 1
Title
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Time Frame
Day 150 post-dose 1
Title
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Time Frame
Day 150 post-dose 1
Title
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Time Frame
Day 150 post-dose 1
Title
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Description
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.
Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Time Frame
Day 0 up to Day 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Days
Maximum Age & Unit of Time
71 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria :
Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.
Hepatitis B vaccination since birth.
Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria :
Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
Chronic illness at a stage that could interfere with trial conduct or completion.
Blood or blood-derived products received since birth.
Any vaccination in the 4 weeks preceding the first trial vaccination.
Any planned vaccination (except trial vaccinations) during the trial.
Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
History of seizures.
Febrile (rectal equivalent temperature >= 38.0°C) or acute illness on the day of inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Bangkok
Country
Thailand
City
Khonkaen
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
21334243
Citation
Kosalaraksa P, Thisyakorn U, Benjaponpitak S, Chokephaibulkit K, Santos-Lima E. Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants. Int J Infect Dis. 2011 Apr;15(4):e249-56. doi: 10.1016/j.ijid.2010.12.004. Epub 2011 Feb 18.
Results Reference
result
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
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