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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
DTaP-IPV-HB-PRP~T
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
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, Whooping cough, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b

Eligibility Criteria

50 Days - 70 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

  • Infant of either gender, aged 50 to 70 days inclusive
  • Mother is negative for HBsAg
  • Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
  • Written informed consent form signed by at least one parent or by another legal representative and an independent witness
  • Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Exclusion Criteria :

  • Axillary temperature ≥37.1°C on the day of inclusion
  • Current or planned enrolment in another clinical trial during the clinical trial period
  • Known mother's history of Human Immunodeficiency Virus (HIV) infection
  • Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
  • Receipt of blood-derived products since birth
  • Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
  • Occurrence of seizures since birth
  • Hypersensitivity to any of the vaccine components
  • Coagulopathy contraindicating intramuscular injection
  • History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
  • History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
  • Vaccination within the last 4 weeks.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

DTaP IPV HB-PRP~T vaccine group

PENTAXIM™ and ENGERIX B® vaccines group

Outcomes

Primary Outcome Measures

Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).

Secondary Outcome Measures

Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.

Full Information

First Posted
January 27, 2009
Last Updated
November 21, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00831311
Brief Title
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Official Title
Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
March 2007 (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
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: To describe in each group the immunogenicity parameters one month after the three-dose primary series. To describe safety profile after each vaccination in both groups.

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, Poliomyelitis
Keywords
Diphtheria, Tetanus, Pertussis, Whooping cough, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
624 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DTaP IPV HB-PRP~T vaccine group
Arm Title
2
Arm Type
Active Comparator
Arm Description
PENTAXIM™ and ENGERIX B® vaccines group
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-HB-PRP~T
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
Other Intervention Name(s)
PENTAXIM™, ENGERIX B® PEDIATRICO
Intervention Description
0.5 mL, Intramuscular (right and left thighs, respectively)
Primary Outcome Measure Information:
Title
Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Description
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Time Frame
1 month post last vaccination
Title
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Description
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Time Frame
Day 150 (1 month post-vaccination 3)
Title
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Description
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Time Frame
Day 150 (1 month post-vaccination 3)
Title
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Description
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Time Frame
Day 150 (1 month post-vaccination 3)
Secondary Outcome Measure Information:
Title
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Description
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites
Time Frame
Day 0 up to Day 7 post-vaccination
Title
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Description
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.
Time Frame
Day 0 up to Day 7 post-vaccination
Title
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Description
Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.
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
70 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria : Infant of either gender, aged 50 to 70 days inclusive Mother is negative for HBsAg Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg Written informed consent form signed by at least one parent or by another legal representative and an independent witness Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial. Exclusion Criteria : Axillary temperature ≥37.1°C on the day of inclusion Current or planned enrolment in another clinical trial during the clinical trial period Known mother's history of Human Immunodeficiency Virus (HIV) infection Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days) Receipt of blood-derived products since birth Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial Occurrence of seizures since birth Hypersensitivity to any of the vaccine components Coagulopathy contraindicating intramuscular injection History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections Vaccination within the last 4 weeks.
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
Córdoba
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
21372751
Citation
Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.
Results Reference
result
Links:
URL
http://www.sanofipasteur.com
Description
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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

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