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Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DTaP-IPV-HB-PRP~T
Tritanrix-HepB/Hib
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Recombinant Hepatitis B, Poliomyelitis, Haemophilus influenzae type b, Tetanus protein

Eligibility Criteria

50 Days - 71 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 2 months old infants on the day of inclusion Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses Able to attend all scheduled visits and to comply with all trial procedures Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life. 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 Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Subjects with congenital or acquired immunodeficiency in the child's surrounding 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 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 Vaccination planned in the 4 weeks following the trial vaccination Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination History of seizures Febrile 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

Group 2: Tritanrix-Hep B/Hib™+OPV

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

Secondary Outcome Measures

Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.

Full Information

First Posted
April 11, 2006
Last Updated
April 2, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00313911
Brief Title
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Official Title
Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
February 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
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
Keywords
Diphtheria, Tetanus, Pertussis, Recombinant Hepatitis B, Poliomyelitis, Haemophilus influenzae type b, Tetanus protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: DTaP-IPV-Hep B-PRP-T
Arm Type
Experimental
Arm Title
Group 2: Tritanrix-Hep B/Hib™+OPV
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-HB-PRP~T
Intervention Description
0.5 mL, Intramuscular (IM)
Intervention Type
Biological
Intervention Name(s)
Tritanrix-HepB/Hib
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
Description
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Time Frame
Day 0 up to Day 7 post-injection
Secondary Outcome Measure Information:
Title
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Description
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Time Frame
Day 30 post-dose 3
Title
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Description
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Time Frame
Day 30 post-dose 3
Title
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Description
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Time Frame
Day 0 up to Day 7 Post-injection

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: 2 months old infants on the day of inclusion Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses Able to attend all scheduled visits and to comply with all trial procedures Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life. 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 Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Subjects with congenital or acquired immunodeficiency in the child's surrounding 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 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 Vaccination planned in the 4 weeks following the trial vaccination Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination History of seizures Febrile 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
Mexico DF
Country
Mexico
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
22531237
Citation
Macias M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126-32. doi: 10.1097/INF.0b013e318258400d.
Results Reference
result
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

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