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Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
Infanrix Hexa™
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, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b., Haemophilus Influenzae Type B Infection

Eligibility Criteria

15 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
  • Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
  • Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
  • 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 booster vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
  • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 in the last 3 months.
  • Any vaccination in the 4 weeks preceding the booster vaccination.
  • Any vaccination planned until the next visit.
  • History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
  • Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
  • Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
  • Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
  • Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
  • History of seizures.
  • Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
  • Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

DTaP-IPV-Hep B-PRP~T Batch 1

DTaP-IPV-Hep B-PRP~T Batch 2

DTaP-IPV-Hep B-PRP~T Batch 3

Infanrix Hexa™

Arm Description

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Outcomes

Primary Outcome Measures

Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2008
Last Updated
April 8, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00654901
Brief Title
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Official Title
Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™. To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects. Safety - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
881 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DTaP-IPV-Hep B-PRP~T Batch 1
Arm Type
Experimental
Arm Description
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Arm Title
DTaP-IPV-Hep B-PRP~T Batch 2
Arm Type
Experimental
Arm Description
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Arm Title
DTaP-IPV-Hep B-PRP~T Batch 3
Arm Type
Experimental
Arm Description
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Arm Title
Infanrix Hexa™
Arm Type
Active Comparator
Arm Description
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Infanrix Hexa™
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Description
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Time Frame
Day 0 (pre-booster) and Day 30 (one month post-booster)
Title
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Description
Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Time Frame
Day 0 (pre-booster) and Day 30 (one month post-booster)
Title
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Description
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.
Time Frame
Days 0 up to 7 after any injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses 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 booster vaccination. Planned participation in another clinical trial during the present trial period. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy. Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 in the last 3 months. Any vaccination in the 4 weeks preceding the booster vaccination. Any vaccination planned until the next visit. History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically). Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11. Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity. Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11. History of seizures. Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Estado de Mexico
Country
Mexico
City
Insurgentes Cuicuilco
Country
Mexico
City
Monterrey
Country
Mexico
City
Puebla
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

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